BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1041197 · Received May 9, 2008

    Report

    Report Number
    1823260-2008-03886
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    May 4, 2008
    Report Date
    May 9, 2008
    Manufacturer
    OROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE COMPACT PLUS SYSTEM WITH RESULTS OF: 77 MG/DL, 158 MG/DL AND 180 MG/DL. 167 MG/DL, 150MG/DL, 232MG/DL, AND 98MG/DL. 150MG/DL, 232MG/DL, 98MG/DL AND 98MG/DL. L1 QUALITY CONTROL WAS RUN AND IN RANGE. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT 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 OROCHE DIAGNOSTICS 20677341

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR