BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1761302 · Received July 20, 2007

    Report

    Report Number
    1823260-2007-06379
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    July 10, 2007
    Report Date
    July 20, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 25 MG/DL, 80 MG/DL, AND 81 MG/DL. NO ADVERSE EVENT REPORTED. NO ACTION WAS TAKEN BASED ON DEVICE RESULTS. REQUESTED RETURN OF SUSPECT DEVICE AND 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 ROCHE DIAGNOSTICS 20660041

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR NPH 15 OR 16UNITS 2/DAILY