BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1060090 · Received June 11, 2008

    Report

    Report Number
    1823260-2008-04628
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 11, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 84 MG/DL, 86 MG/DL AND 166 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINS ON THE COMPACT SYSTEM. NO ACTIONS WERE REPORTEDLY TAKEN OR TREATMENT REC'D. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PROD WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR PAXIL 20MG ONCE DAILY| ZOCOR 20MG ONCE DAILY| GLUCOPHAGE - 500MG ONCE DAILY