BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1771974 · Received September 18, 2007

    Report

    Report Number
    1823260-2007-08182
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    August 31, 2007
    Report Date
    September 18, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE USE BY DATE ON THE TEST STRIP VIAL IS 12/31/2008; MANUFACTURER'S DATABASE AND BATCH RECORD CONFIRMED THE ACTUAL USE BY DATE TO BE 12/31/2005. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE - LFR LFR ROCHE DIAGNOSTICS 548158

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR GLUCOPHAGE - 500 MG TWICE DAILY - 10 YEARS| MICRONASE - 5 MG 3/DAY - 10 YEARS