Accu-Chek® Mobile:

System Evaluation (ISO 15197:2013)

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 Authors:
Hans Kintzig
Manfred Kraft
Tiina Lappi
Klaus Rinck

2nd edition 2014

Roche Diagnostics GmbH, Mannheim, Germany

2
Table of Contents
The Accu-Chek Mobile system5
Introduction5

The main features at a glance 6

Specifications of the Accu-Chek Mobile system 7

Performing a blood glucose test with the Accu-Chek Mobile system 9

The Accu-Chek Mobile test cassette 9

The Accu-Chek Mobile test principle 10

The Accu-Chek Mobile control solutions 11

Performance evaluation of the Accu-Chek Mobile system12

Accuracy according to ISO 15197:2013 12

User performance evaluation according to ISO 15197:2013 14

Measurement repeatability in accordance with ISO 15197:2013  15

Intermediate precision in accordance with ISO 15197:2013  16

Potentially interfering active substances, blood additives

and endogenous substances  17

Influence of hematocrit according ISO 15197:2013 18

User study under everyday conditions (home use study) 18

Human factors studies 18

Reliability of measurements under various

environmental conditions 19

Environmental conditions 19

Mechanical stress 19

Electromagnetic compatibility (EMC) 19

Safety (electrical/mechanical) 20

Conclusion21

3
Figure 1: The Accu-Chek® Mobile sy­stem

4
The Accu-Chek Mobile system
Introduction

Self-monitoring of blood glucose is essential for the daily strips, providing a new level of convenience to people
self-management of diabetes. It provides the mandatory with diabetes. In addition, the new Accu-Chek Mobile
information for insulin dosing in a flexible insulin therapy blood glucose monitoring system includes an attached
and it helps to identify critically low or high blood lancing device with a 1-Click action to prime and
glucose levels in order to take adequate action. Finally it release in one step, and the Accu-Chek FastClix lancet
provides essential feedback on how life and lifestyle drum with 6 preloaded lancets. The strip-free
affects the blood glucose level, i. e. food intake, sport, stress Accu-Chek Mobile system provides all that is needed to
or infections. In all cases it enables the patient and/or monitor blood glucose- making it easier, especially for
the treating physician to take adequate action in order to insulin-treated patients. The new Accu-Chek Mobile
optimize overall glycemic control and to reduce the system is not only strip-free and simple, it is also smart.
number of hypo- and hyperglycemic events. Its integrated reporting function allows for easy blood
glucose visualization and puts blood glucose values into
Self-monitoring of blood glucose must be integrated context, helping to make decisions for optimized diabetes
smoothly into the individual life of people with diabetes. management.
Research has indicated that a significant portion of
patients struggle to adhere to their recommended self- The Accu-Chek Mobile system consists of the
monitoring regime. Significant obstacles are difficulties Accu-Chek Mobile blood glucose monitoring system,
in handling test strips and the testing procedure, lifestyle the Accu-Chek Mobile test cassette, the attached
alignment (e.g lack of time or testing away from home) Accu-Chek FastClix M1 lancing device and the
and forgetfulness.1, 2 Accu-Chek FastClix lancet drum.

Results from the multicenter, prospective controlled study Also available is the Accu-Chek Mobile control solution
(ExAct) showed that the use of Accu-Chek Mobile system and the Accu-Chek FastClix M1 AST cap, a special cap
resulted in an increased SMBG frequency towards for blood sampling from alternative sites.
guideline recommendations in non-adherent patients as
compared to single-strip system. It was associated with
overall better glycemic control in non-adherent patients.
It led to a greater proportion of patients achieving clinically
relevant decreases in HbA1c with glycemic improvement
throughout the study period.3, 4

The strip-free Accu-Chek Mobile blood glucose 1

Wijsman I. Patient-reported barriers in diabetes management and
monitoring system has resulted from the refinement of areas of opportunity for health care professionals. Poster presentation
the first generation of the Accu-Chek Mobile system: at the 14th Annual Conference of the Federation of European Nurses
in Diabetes (FEND); 2009 September 25–26; Vienna, Austria
The main differentiating factor remains the test cassette
with 50 strip-free tests on a continuous tape. This 2
Batten L. Survey of blood glucose testing among Diabetes UK lay
eliminates the need to handle or dispose of single test members. Crossbow Research, April 2004

3
Maran A. et al.: Use of an integrated strip-free blood glucose monito-
ring system increases frequency of self-monitoring and improves
glycemic control: results from the ExAct study. Journal of Clinical &
Translational Endocrinology 1 (2014) 161–166

4
Fortwaengler K. et al. Better Adherence and Glycemic Control with the
Integrated Strip-Free Accu-Chek Mobile System at Marginal Extra Cost –
Learnings From the ExAct Study. Diabetes Technology & Therapeutics
(2014) 16: [Suppl 1]

5
The main features at a glance

50 strip-free tests on a continuous tape Target range for results

The test cassette contains 50 strip-free tests on a The user can set an individual target range for blood
continuous tape. This eliminates the need to handle or glucose values. The target range gives the blood glucose
dispose of single test strips. values which should be achieved if the treatment is
optimal. If a result is above or below this range, a symbol
Easy lancing with 1-Click-action to prime and on the display will draw attention to this.
release in one step
The Accu-Chek FastClix M1 lancing device offers a new Flagging results
feature, 1-Click lancing, allowing priming and lancing to The user can flag results with various symbols which
be done in one single step (just press the release button indicate particular situations during the test
once). It can be used both attached to and detached from (pre- or post-meal, other). In addition, results can
the Accu-Chek Mobile system. also be flagged as a control test.

6 preloaded lancets in a drum Large memory

The Accu-Chek FastClix lancet drum containing 6 sterile The system automatically saves up to 2,000 results with the
lancets is placed in the lancing device. This means time and date of the test and all other information flagged
that there is no need to see or touch single lancets. The in association with the test.
user can easily advance to the next sterile lancet by
pushing the lancet changer back and forth. Integrated data analysis
From the stored results, the system can calculate the
Automatic coding – no manual coding averages for the last 7, 14, 30 or 90 days.
required by the user
Each test cassette contains an RFID (radiofrequency Connectivity via micro USB port
identification) chip. This automatically codes the system The Accu-Chek Mobile system has a micro USB port
when a test cassette is inserted and informs the system to enable connectivity to a Personal Computer (PC).
about the specific properties of this test cassette. Three features are available to the user when the
Accu-Chek Mobile system is connected to a PC, (1) view
Text supported operation PC-ready reports, (2) transfer data to a data management
The system takes the user through all the operations program, and (3) transfer a Comma Separated Value (CSV)
step by step in the language selected. Currently file to the PC.
the Accu-Chek Mobile system supports more than
20 languages. The text is supported by symbols and PC-ready reports (Integrated reporting function)
graphics where necessary. The integrated reporting function called PC-ready reports
allows for easy blood glucose visualization without the
Test reminders need to install software or obtain specialized hardware.
The user can set a test reminder after a test has been Four different reports (Trend Report, Standard Day Report,
performed. These reminders can be set to occur in Standard Week Report and List Report) are presented in
1, 1.5, 2, or 3 hours in the future and occur only once. In an Internet browser.
addition up to seven standard individually programmable
test reminders, which are repeated daily, can be set. Failsafes
When either type of test reminder occurs, the user can Before starting a test and during testing the
directly initiate a test via the user interface. Accu-Chek Mobile system performs several quality
checks or sanity checks, e.g. whether sufficient blood
has been applied. This ensures accurate results.

6
 Specifications of the Accu-Chek Mobile system
Model Accu-Chek Mobile model U1
Measuring principle Photometric determination of glucose by means of a mutant variant of the quino-protein glucose
dehydrogenase with colour indication (Mut. Q-GDH 2, modified variant of EC 1.1.5.2), acinetobacter spec.
Measuring range 10–600 mg/dL (0.6–33.3 mmol/L)
Measuring time Approximately 5 sec (depending on the blood glucose concentration)
Operating conditions Temperature: +10 to +40°C (+50 to +104 °F)
Humidity: 15 to 85% relative humidity
Sample material Fresh capillary blood
Sample size 0.3 µL (min. sample size), 5.0 µL (max. sample size)
Sample dosing Blood applied to the middle of the yellow test area. The test area absorbs the blood quickly and
hygienically (spread technology).
Under-dosing detection Yes
Hematocrit range 25–55 %
Altitude independence 0–4,000 m (0–13,123 feet)
Test capacity of the cassette 50 tests
Coding Automatic coding via RFID tag on the test cassette surface. No manual coding required by the user.
Reference method Hexokinase with deproteinization, converted into plasma values according to IFCC recommendation
(plasma values are 11% higher than whole blood values)
Event flag 4 different flags: Control solution, before or after meal, other
Display Dot matrix OLED display with 100 x 128 pixels
Display text Yes, information displayed in a combination of text, icons and animations
Languages The Accu-Chek Mobile system currently supports 25 languages. The displayed list of languages is set
according to the country of distribution before delivery. Hence it is possible that not all languages will be
available in all devices.
Memory capacity 2000 measurements automatically saved with the time, date and all other information flagged in
association with the test.
Statistics Average calculation is possible for: All values, only before meal values, only after meal values,
based on 7, 14, 30 and 90 days
Reminder User can set a reminder after a test to perform another test in 1, 1.5, 2, or 3 hours time. Up to 3 of these
reminders can be active at any one time. User can set 7 standard, individually programmable reminders
which are repeated daily.
Error messages & warnings In the case that an error occurs, the system communicates not only the error code to the user, but also the
cause of the error, and what the user can do to prevent the error from happening again.
Acoustic data output Data output with audible beeper sequences for visually impaired PWD’s
Information management Data transfer via Micro USB (Universal Serial Bus) port
Data transfer to Roche software
Data visualization via PC-ready reports (see paragraph “Specification of PC-ready reports”)
Dimensions 121 x 63 x 20 mm (with attached lancing device)
Weight Approx. 129 g (with lancing device, batteries, test cassette and lancet drum)
Batteries 2 alkaline-manganese or high energy batteries (1.5 V, type AAA, LR 03, AM 4 or micro)
Battery life Approx. 500 tests or approx. 1 year
Auto power off After 1 or 2 minute(s), depending on the operating status
Storage conditions Meter without batteries and without test cassette: –25 to +70°C (–13 to +158 °F)
Meter with batteries and without test cassette: –10 to +50°C (+14 to +122 °F)
Meter with batteries and with test cassette: +2 to +30°C (+36°F to +86 °F)
Humidity: 15 to 93% relative humidity
Special feature Detachable lancing device

Table 1: Specifications of the Accu-Chek Mobile system

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 Specifications of the Accu-Chek FastClix M1 lancing device
Depth setting 11 depth settings, depth selection by rotating the cap
Depth setting range 0.7 to 2.2 mm
Priming & releasing of device 1-Click Lancing: Press once to lance
Changing the lancet drum Remove cap, pull out drum from device
Advancing to next sterile lancet On demand: by sliding the lancet changer back and forth
Indication of remaining lancets Number of available lancets is indicated in the lancet counter window
Size of device, detached Length 118 mm, diameter 19 mm
Weight, detached (with lancet drum) Approximately 20.1 g including lancet drum
AST-capability With special AST cap (grey-black with transparent bottom)
Lancet drum disposable Accu-Chek FastClix lancet drum containing 6 sterile lancets with a needle diameter of 0.3 mm (30 G)
Disposal of used lancet drums In regular household waste if this is allowed by the local regulations

Table 2: Specifications of the Accu-Chek FastClix M1 lancing device

Specifications of the PC-ready reports

System requirements A PC running an internet browser compliant with the HTML standard, e.g. Mozilla Firefox
Express download + print without Yes
saving the data
Reports Four different reports (Trend Report, Standard Day Report, Standard Week Report and List Report)
available, time range can be selected (3, 7, 14, 30, 90 days)
Save function As .csv file
Special features No need to install software or obtain specialized hardware, no internet connection necessary

Table 3: Specifications of the PC-ready reports

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Performing a blood glucose test with the Accu-Chek Mobile system

The Accu-Chek Mobile system allows easy and convenient insulin-treated patients to easily monitor their blood
testing of blood glucose. The strip-free technology helps glucose in just four simple steps.

1 2 3 4

Prick your finger with the Apply the blood drop to the centre Testing is complete after approx.
Open tip cover. The meter
lancing device to obtain a small, of the test area. Touch the test area 5 seconds. Read the test result
turns on. The fingers have to
well-formed drop of capillary gently and briefly. Remove the and close the tip over. The meter
be washed!
blood. finger when the beep tone sounds. turns off.

Figure 2: Blood glucose testing with the Accu-Chek Mobile system

The Accu-Chek Mobile test cassette

The Accu-Chek Mobile test cassette contains a After a blood glucose measurement has been completed,
continuous tape with 50 strip-free tests. The test cassette the used test area is spooled back into the test cassette
is comparable to an audio cassette and contains two and stored on the “waste spool”.
spools (Figure 3). The fresh tests are coiled on the
“good spool”. Moving to the “waste spool” the tape is The test tape consists of an adhesive carrier foil with
guided over the tip of the test cassette. The system detects 50 test areas (Figure 4). The glucose determination
the position markers of the tape and stops when the test reaction occurs in the reactive film of each test area.
area is placed exactly above the tip of the test cassette. The minimum sample size needed to start a measurement
is 0.3 µL.

Test tape

Blood application Waste spool

point

Good spool

Figure 3: Schematic drawing of the Accu-Chek Mobile test cassette

9
Figure 4: Schematic drawing of the Accu-Chek Mobile test tape

The Accu-Chek Mobile test principle

The determination reaction and colour formation occur in photometry and converts it into the corresponding
the reagent layer (Figure 5). The system measures the glucose concentration. The glucose measurement range
intensity of the colour formed in the reaction by reflectance is between 10 and 600 mg/dL (0.6–33.3 mmol/L).

Glucose Gluconolactone

The enzyme, a mutant variant of the quino-protein glucose

dehydrogenase (Mut. Q-GDH 2), oxidizes β-D-glucose
Enzyme Enzyme
to D-5-gluconolactone, reducing the enzyme-bound coenzyme
(PQQ)ox (PQQH2)red PQQ (= pyrroloquinoline quinone) to PQQH2.

Mediator red Mediator ox

Indicator ox Indicator red

(yellow) (blue)

Figure 5: Determination reaction in the reactive film of the test area

10
The Accu-Chek Mobile control solutions

Measurements with control solution should be done from

time to time to check the system, e.g. after insertion of
a new test cassette, after changing the batteries, after
cleaning the inside of the system or when there is doubt
about a result.

The Accu-Chek Mobile control solution is provided in

single-use applicators in different concentration ranges
(Figure 6). These are designed for single use only and do
not serve for multiple application. Different control
solution glucose levels are sold in different countries. To
perform a control test, a glucose control solution is applied
to the test area instead of blood. After the measurement
with control solution the user has to flag the result as a
control test (the symbol C appears in the display). At the
end of the test, the system automatically checks whether
the result obtained with glucose control solution is correct
and informs the user of the result. Figure 6: The Accu-Chek Mobile control solutions

11
Performance Evaluation
of the Accu-Chek Mobile system
The performance of the Accu-Chek Mobile system was Accuracy according to ISO 15197:2013
evaluated carefully at internal and external evaluation sites Evaluation site 2
to prove reliability of measurement and consistency with
regulatory requirements. One hundred capillary blood samples fulfilling the glucose
concentration range distribution as specified in the
External evaluation
standard were measured with 3 test strip lots on
1 H. Regal Clinical Chemist, Investigator
Diabetes Centre G. Sokol, Vienna, Austria 2 different Accu-Chek Mobile meters (U1) per lot. The
2 G. Freckmann General Manager
Accu-Chek Mobile system results were compared with
A. Baumstark Department head
“blood glucose monitoring systems” the results obtained with the hexokinase method with
Institute for Diabetes-Technology
deproteinization (converted into plasma values by the
at the University of Ulm, Germany factor 1.11 according to IFCC recommendation). The
3 R. Fischer Test Engineer
TÜV SÜD Product Service GmbH,
results of the method comparison are presented in tables
München, Germany 5 and 6. Figures 7, 8 and 9 presents the data graphically.
4 C. Pottiez Project Manager Evaluation & Usability
M. Reismann Senior Director Usability Research 597 of 600 results are within the minimum acceptable
Spiegel Institute Brühl, Germany performance criteria of within ± 15 mg/dL at glucose
Internal evaluation
concentrations < 100 mg/dL ≥ or within ± 15 % at
5 K. Rinck Co-Project Leader glucose concentration ≥ 100 mg/dL. 599 of 600 results are
Design Verification and Validation
Roche Diagnostics GmbH, Mannheim, Germany
within zone A and 1 result is in zone B of the Consensus
6 M. Kraft Design Verification and Validation Error Grid. The Accu-Chek Mobile system meets the
I. Keth (System Performance)
Roche Diagnostics GmbH, Mannheim, Germany performance criteria of the standard ISO 15197:2013.

Table 4: Evaluation sites

Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL

Lot No.
(± 0.28 mmol/L) (± 0.56 mmol/L) (± 0.83 mmol/L)
297504 41/52 (78.8 %) 52/52 (100.0 %) 52/52 (100.0 %)
297506 42/52 (80.8 %) 50/52 (96.2 %) 51/52 (98.1 %)
297505 37/52 (71.2 %) 52/52 (100.0 %) 52/52 (100.0 %)
Combined 120/156 (76.9 %) 154/156 (98.7 %) 155/156 (99.4 %)
Table 5: System accuracy results for glucose concentrations < 100 mg/dL

Lot No. Within ± 5 % Within ± 10 % Within ± 15 %

297504 59/148 (39.9 %) 136/148 (91.9 %) 147/148 (99.3 %)
297506 91/148 (61.5 %) 145/148 (98.0 %) 148/148 (100.0 %)
297505 66/148 (44.6 %) 129/148 (87.2 %) 147/148 (99.3 %)
Combined 216/444 (48.6 %) 410/444 (92.3 %) 442/444 (99.5 %)
Table 6: System accuracy results for glucose concentrations ≥ 100 mg/dL
Evaluation site 2

12
 mmol/L mg/dL mmol/L mg/dL
33.4 600 33.4 600
Glucose, Accu-Chek Mobile, Lot 297504

Glucose, Accu-Chek Mobile, Lot 297505

27.8 500 27.8 500

22.2 400 22.2 400

16.7 300 16.7 300

11.1 200 11.1 200

5.6 100 5.6 100

r = 0.998 r = 0.998
n = 200 n = 200

0 0 0 0
0 100 200 300 400 500 600 0 100 200 300 400 500 600
0 5.6 11.1 16.7 22.2 27.8 33.4 0 5.6 11.1 16.7 22.2 27.8 33.4
Glucose,  Hexokinase Method    Glucose,  Hexokinase Method   

Figure 7: Figure 9:
Method comparison test strip lot 297504 vs. hexokinase with deproteini- Method comparison test strip lot 297505 vs. hexokinase with deproteini-
zation. Sample material: capillary blood zation. Sample material: capillary blood

Regression data: Y = 2.67 mg/dL ( 0.15 mmol/L) + 0.932 X Regression data: Y = 5.06 mg/dL ( 0.28 mmol/L) + 0.926 X
Evaluation site 2

mmol/L mg/dL
33.4 600
Glucose, Accu-Chek Mobile, Lot 297506

27.8 500

22.2 400

16.7 300

11.1 200

5.6 100
r = 0.998
n = 200

0 0
0 100 200 300 400 500 600
0 5.6 11.1 16.7 22.2 27.8 33.4
Glucose,  Hexokinase Method   

Figure 8:
Method comparison test strip lot 297506 vs. hexokinase with deproteini-
zation. Sample material: capillary blood

Regression data: Y = 3.69 mg/dL ( 0.20 mmol/L) + 0.946 X

13
User performance evaluation according
to ISO 15197:2013
Evaluation site 2

To demonstrate that users (patients with diabetes) are 97.1% (101 out of 104) of the results obtained by
able to operate the blood glucose monitoring system and users were within ± 15 mg/dL of the results obtained
obtain accurate glucose results, when given only the with the hexokinase method at glucose concentrations
instructions routinely provided with the system, a user < 100 mg/dL or within ± 15 % at glucose concentrations
performance evaluation according to ISO 15197:2013, ≥ 100 mg/dL (≥ 4.2 mmol/L).
section 8, was carried out.
It was demonstrated that users are able to operate the
Capillary blood was measured by users with the Accu-Chek Mobile system and obtain accurate glucose
Accu-Chek Mobile system. The results obtained results, when given only the instructions routinely provided
by the users were compared to results obtained with with the system.
the hexokinase method.

14
Measurement repeatability in accordance with
ISO 15197:2013
Evaluation site 6

Measurement repeatability was performed using

heparinized venous blood samples in five glucose
concentration ranges see table 7 in accordance
with ISO 15197:2013 on ten Accu-Chek Mobile
meters and three test strip lots. For each test cassette
lot each venous blood sample was measured
ten times on ten systems, so that 100 individual
measurements were generated with each sample.
The results were provided in table 8.

Venous blood Glucose Concentration Ranges

sample No. mg/dL mmol/L
1 30 to 50 1.7 to 2.8
2 51 to 110 2.9 to 6.1
3 111 to 150 6.2 to 8.3
4 151 to 250 8.4 to 13.9
5 251 to 400 14.0 to 22.2
Table 7: Glucose concentration ranges

Measurement Repeatability using Heparin Venous Blood

Sample material:
Heparin venous blood Sample 1 Sample 2 Sample 3 Sample 4 Sample 5
N 300 300 300 300 300
Total Mean [mg/dL] 43 75 128 214 326
Total Mean [mmol/L] 2.4 4.2 7.1 11.9 18.1
Pooled Standard deviation [mg/dL] 2.0 2.3 3.1 4.3 7.1
Pooled Standard deviation [mmol/L] 0.11 0.13 0.17 0.24 0.39
Pooled CV [%] 4.7 3.0 2.4 2.0 2.2
Table 8: Measurement repeatability using heparin venous blood

15
Intermediate precision in accordance
with ISO 15197:2013
Evaluation site 6

Intermediate measurement precision was performed In addition, in accordance with ISO 15197:2013,

with Accu-Chek Mobile (Mut. Q-GDH 2) test cassettes the total mean, pooled variance, pooled SD and
(lots 297504, 297505 and 297506) and Accu-Chek Mobile pooled CV were calculated for each glucose
(Model U1). 3 glucose control solutions with glucose ­concentration­ using the 300 measurement results
concentrations in accordance with ISO 15197:2013 from all 3 cassette lots.
were used (see table 9).
The criteria for glucose stability were met for
For each test cassette lot, each glucose solution was all glucose solutions. The acceptance criteria
measured once per day on 10 meters on 10 days, were met for each lot and glucose solution.
so that 100 individual measurements were generated.
One test cassette was allocated to each meter.

The mean, standard deviation (SD), and coefficient

of variation (CV) were calculated for each concen­
tration range and lot (100 values). The 95 %
confidence interval (CI) was calculated for the
SD and CV in each case.

Glucose solution Glucose Concentration

No. mg/dL mmol/L
1 30 to 50 1.7 to 2.8
2 96 to 144 5.3 to 8.0
3 280 to 420 15.5 to 23.3
Table 9: Glucose concentration ranges

Concentration Range [mg/dL] [mmol/L]

30 to 50 96 to 144 280 to 420
1.7 to 2.8 5.3 to 8.0 15.5 to 23.0
N 300 300 300
Total mean [mg/dL]/[mmol/L] 44/2.4 126/7.0 390/21.7
Pooled SD [mg/dL]/[mmol/L] 2.0/0.1 2.8/0.2 7.8/0.4
Pooled CV [%] 4.6 2.2 2.0
Table 10: Intermediate precision based on the pooled data for 3 lots, according ISO 15198:2013

16
Potentially interfering active substances,
blood additives and endogenous substances
Evaluation site 6

28 substances were tested in heparinized venous blood For results within the limits of ± 10 mg/dL or ± 10 %,
samples for their potential for interference. The procedure the test substance is considered to be not interfering.
was in accordance with ISO 15197:2013. A substance is
considered as an interferent if the calculated difference In cases where the interference effect of the substances
between the test sample and the blank sample (control met the acceptance criteria, a dose-response evaluation
sample) meets either of the following acceptance criteria: was performed to determine the degree of interference as
a function of the test substance concentration.
For samples with glucose concentrations < 100 mg/dL,
the mean bias per lot for each glucose/test substance Results of the dose-response evaluation
combination exceeds ± 10 mg/dL. • Ceftriaxone: The concentration where the interference
just exceeds the acceptance criteria is
For samples with glucose concentrations ≥ 100 mg/dL, 26 mg/dL (469 µmol/L).
the mean bias per lot for each glucose test substance • Galactose: The concentration where the interference
combination exceeds ± 10 %. just exceeds the acceptance criteria is
20 mg/dL (1097 µmol/L).

Test substance Evaluation result

Acetaminophen (paracetamol) No interference
Albumin human No interference
Ascorbate (L-ascorbic acid) No interference
Bilirubin conjugated No interference
Bilirubin unconjugated No interference
Ceftriaxone Interference see pack insert
Cholesterol No interference
Creatinine No interference
Dopamine No interference
EDTA No interference
Galactose Interference see pack insert
Gentisic acid No interference
Glutathione (reduced) No interference
Hemoglobin No interference
Heparin Li No interference
Heparin Na No interference
Ibuprofen No interference
Icodextrin No interference
L-DOPA (L-3,4-dihydroxyphenylalanine No interference
Maltose No interference
Methyldopa No interference
Pralidoxime iodide (PAM) No interference
Salycylate (salicylic acid) No interference
Tolazamide No interference
Tolbutamide No interference
Triglycerides (lipids) No interference
Urate (uric acid) No interference
Xylose No interference
Table 11: Summary of results of testing potentially interfering substances

17
Influence of hematocrit according ISO 15197:2013 Glucose results obtained with the Accu-Chek Mobile
Evaluation site 6 system and those obtained with other systems showed a
very good correlation, i.e. the accuracy of the Accu-Chek
Objective Mobile system was very high.
To demonstrate that the blood glucose monitoring system Reproducibility of measurements using the system specific
provides correct glucose measurements in accordance control solution was very good.
with ISO 15197:2013 within the hematocrit range of 25 %
to 55 %. System handling and ease of use were highly appre-
ciated. The system’s functions and features were rated very
Acceptance Criteria positively. The instructions for use were assessed to be
To demonstrate that results are not biased by hematocrit comprehensible. Overall user satisfaction was high.
within a hematocrit range of 25 % to 55 %, the mean
normalized bias for each lot and glucose/hematocrit
combination shall not exceed the following tolerance Human factors studies
limits: Evaluation sites 2 and 4
±10 mg/dL (glucose concentration < 100 mg/dL)
±10 % (glucose concentration ≥ 100 mg/dL) Human factors studies on the Accu-Chek Mobile system
were performed to show that the new system fulfills
all Roche and regulatory requirements, particularly the
Results usability standard IEC 62366:2007.
The acceptance criteria were met for the hematocrit range
of 25 % to 55 %. In total 53 persons participated in two human
None of the mean normalized bias values exceeded factors studies. The results showed that the
± 10 mg/dL or 10%. Accu-Chek Mobile system fulfills all Roche and
regulatory requirements.
Conclusion
The system provides correct glucose measurements within
the hematocrit range of 25 % to 55 %.

User study under everyday conditions

(home use study)
Evaluation site 1

30 subjects with type 1 and 2 diabetes, aged 28 to 81 years,

with a broad range of experience in blood glucose self-
monitoring, tested the Accu-Chek Mobile system in
everyday life. During the study the subjects performed
blood glucose measurements using the Accu-Chek Mobile
system including the Accu-Chek Fastclix M1 lancing
device in parallel to the routinely performed self-testing
with their own blood glucose monitoring system.

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Reliability of measurements under
various environmental conditions
A blood glucose monitoring system which constantly Drop test
accompanies a person with diabetes is often exposed to The blood glucose monitoring systems were dropped
severe stress; however, this must not impair the function of from a height of one meter onto concrete floor.
the system. The Accu-Chek Mobile system had to withstand being
dropped onto each of its 6 sides without any impairment
As part of a technical evaluation, the reliability of the of measuring results.
Accu-Chek Mobile system was tested for compliance with
regulatory requirements under extreme environmental Long-term stress
conditions. To simulate mechanical stress to which an
Accu-Chek Mobile system can be exposed in its lifetime,
The tests consisted of climatic stress tests, mechanical at least 6,500 measuring cycles per system were
stress tests, electromagnetic compatibility and technical performed with a set of Accu-Chek Mobile systems.
safety.
Checks made following individual testing revealed no
impairment of operating and measuring performance.
Environmental conditions
Evaluation site 5
Electromagnetic compatibility (EMC)
Climatic stress Evaluation site 5
In a climatic stress test, Accu-Chek Mobile systems were
exposed to cycles of differing temperature and humidity Resistance to interference from high-frequency
conditions during operation. The limit values were 10°C electromagnetic fields
and 40°C, and 85% relative humidity. This climatic stress On testing for resistance to interference from electro-
test was not found to have any effect on the systems. magnetic fields, no impairment of system function or
measurement result was found. The test procedure
Transportation under extreme climatic conditions applied complied with standard EN 61000-4-3.
In a special transport test, Accu-Chek Mobile systems In accordance to EN ISO 15197 the tested frequency
were exposed to extreme temperature and climatic range was from 80MHz up to 2,500 MHz with a field
conditions. The limit values were –25°C and +70°C, and strength of 3 V/m.
93% relative humidity. The systems were subsequently
examined. No affect on system functioning or measuring Electrostatic discharge (ESD)
performance was found. A test rig in accordance with EN 61000-4-2 was used to
check resistance to interference from electrostatic
discharge as required in EN ISO 15197. Discharges of
Mechanical stress 2 kV to 15 kV were applied to various parts of the
Evaluation site 5 housing, such as the battery compartment, buttons, USB
interface and the display. No damage to the systems
Vibration test investigated or any false glucose measuring results were
Various tests were performed on an electro dynamic observed.
shaker with noise acceleration.
Effects of magnetic fields
Shock test The systems were placed in a Helmholtz coil and exposed
A special shock machine was used to expose systems to to a magnetic field of 50 Hz and 60 Hz with 3 A/m. Here
mechanical shocks of up to 100g. This, combined with too, no effect on system function or measuring results was
the vibration test, simulates rough handling on shipment found.
and transportation.

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Radio interference
With respect to radiated electromagnetic energy, the
Accu-Chek Mobile system fulfills the stringent
class B (for use in the residential environment) under
EN 55011 with an adequate safety margin. An effect
on other electrical appliances or radio connections
(e.g. cordless telephones) by the Accu-Chek Mobile system
can therefore largely be excluded.
The Accu-Chek Mobile system complies with
RTCA DO-160 (section 21, category M), and therefore
can be used on board aircraft.

Safety (electrical/mechanical)
Evaluation site 3

The Accu-Chek Mobile system meets the requirements of

EN 61010-2-101, EN 61010-1/IEC 61010-1 and also of
EN 60950-1/IEC 60950-1 (evidence produced by an
accredited external test laboratory).

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Conclusion
The Accu-Chek Mobile® system was evaluated carefully
at external and internal sites. It showed very good
analytical properties and met all regulatory requirements,
in particular those of the standard ISO 15197:2013.

Furthermore, the new system is characterized by a high

comfort of use.

In summary, the Accu-Chek Mobile system enables

reliable, accurate and precise, but also simple,
comfortable and safe self-monitoring of blood glucose.

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Notice

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Notice

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Experience what’s possible.

ACCU-CHEK, ACCU-CHEK MOBILE and FASTCLIX are trademarks of Roche.

© 2014 Roche Diagnostics.

www.accu-chek.com
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany