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    MAUDE Adverse Event Report - ABBOTT LABORATORIES ARCHITECT I1000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

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    adverse Event Report_ ABBOTT LABORATORIES ARCHITECT I1000SR

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    MAUDE Adverse Event Report - ABBOTT LABORATORIES ARCHITECT I1000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

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    adverse Event Report_ ABBOTT LABORATORIES ARCHITECT I1000SR

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    MAUDE Adverse Event Report_ ABBOTT LABORATORIES ARCHITECT I1000SR; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

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    adverse Event Report_ ABBOTT LABORATORIES ARCHITECT I1000SR

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    MAUDE Adverse Event Report - ABBOTT LABORATORIES ARCHITECT I1000SR ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

    Uploaded by

    shaik Imran Ahmed
    adverse Event Report_ ABBOTT LABORATORIES ARCHITECT I1000SR

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    C

    FDA Home3 Medical Devices4 Databases5


    MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT I1000SR; ANALYZER,
    CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
    6
    510(k)7|DeNovo8|Registration & Listing9|Adverse Events10|Recalls11|PMA12|HDE13|Classification14|Standards15
    CFR Title 2116|Radiation-Emitting Products17|X-Ray Assembler18|Medsun Reports19|CLIA20|TPLC21

    ABBOTT LABORATORIES ARCHITECT I1000SR; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR Back to Search
    CLINICAL USE Results
    Model Number 1L86-01
    Device Problem Leak/Splash (1354)
    Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
    Event Date 01/15/2021
    Event Type malfunction
    Manufacturer Narrative
    Field service replaced the fitting,quick disc,threaded part on the architect for resolution.A review of the architect serial i1sr51347 service history,
    revealed no additional issues of splashing from parts reported on the architect serial i1sr51347.No non-conformances or potential non-
    conformances were identified for the fitting,quick disc,threaded part.A review of the product labeling concluded that the issue is sufficiently
    addressed.The operations manual also addresses biological and chemical safety hazards that includes wearing personal protective equipment
    (ppe) and safety awareness where hazards may exist.The i1000sr service and support manual provides instructions for the removal and
    replacement of the fitting,quick disc,threaded part.No adverse trend was identified for the fitting,quick disc,threaded part.A review of the architect
    product monitoring found no adverse trend of the architect i1000sr with regards to the complaint issue.No product deficiency was identified for
    the complaint issue.

    Event Description
    The operator was splashed on intact skin above the neck when the fitting on the accumulator cap broke on the architect i1000sr.Error 5304,
    (vacuum system error: liquid level too high) was generated on the architect i1000sr.The operator disassembled the rear panel and observed the
    vacuum accumulator was half full of liquid.As soon as the operator touched the tank, one of the fittings on the cap broke and some liquid
    splashed which came into contact with intact skin above the neck of the operator.The operator immediately rinsed the area.No injury or medical
    intervention was reported.No specific patient information provided.No patient involved.

    Search Alerts/Recalls22

    New Search | Submit an Adverse Event Report23

    Brand NameARCHITECT I1000SR


    Type of DeviceANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE),
    FOR CLINICAL USE
    Manufacturer (Section D)ABBOTT LABORATORIES
    1915 Hurd Drive
    Irving TX 75038
    Manufacturer (Section G)ABBOTT LABORATORIES
    1915 Hurd Drive
    Irving TX 75038
    Manufacturer ContactChristian Lee
    100 Abbott Park Road
    Dept. 09b9, Lc Cp01-3
    Abbott Park, IL 60064-3537
    2246682940
    MDR Report Key11258065
    MDR Text Key229601825
    Report Number3016438761-2021-00034
    Device Sequence Number1
    Product CodeJJE 24
    UDI-Device Identifier00380740001537
    UDI-Public00380740001537
    Combination Product (y/n)N
    PMA/PMN NumberEXEMPT
    Number of Events Reported1
    Summary Report (Y/N)N
    Report SourceManufacturer
    Source TypeForeign,Health Professional
    Reporter OccupationOther Health Care Professional
    Type of ReportInitial
    Report Date01/30/2021
    1 Device was Involved in the Event
    1 Patient was Involved in the Event
    Is this an Adverse Event Report?No
    Is this a Product Problem Report?Yes
    Device OperatorHealth Professional
    Device Model Number1L86-01
    Device Catalogue Number01L86-01
    Was Device Available for Evaluation?Yes
    Is the Reporter a Health Professional?Yes
    Initial Date Manufacturer Received01/15/2021
    Initial Date FDA Received02/01/2021
    C
    Was Device Evaluated by Manufacturer?Device Not Returned to Manufacturer
    Date Device Manufactured12/01/2011
    Is the Device Single Use?No
    Is This a Reprocessed and Reused Single-Use Device?No
    Type of Device UsageN
    Patient Sequence Number1

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