BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1760993 · Received July 17, 2007

    Report

    Report Number
    1823260-2007-06170
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    June 28, 2007
    Report Date
    July 17, 2007
    Manufacturer
    ROCHE 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 STATES HE TESTED ON HIS COMPACT SYSTEM TWICE, "WITHIN A FEW MINUTES." THE FIRST RESULT WAS 258 MG/DL AND THE SECOND RESULT WAS 94 MG/DL. NO ACTIONS OR INACTIONS TAKEN BASED ON RESULTS. NO ADVERSE EVENTS. REQUESTED RETURN OF SUSPECT DEVICE AND PLACEMENT 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 20661842

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR GLIPIZIDE - 5MG TWICE DAILY - 7 YEARS