BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1771226 · Received February 18, 2008

    Report

    Report Number
    1823260-2008-01641
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 220 MG/DL AND 112 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. ALSO REPORTEDLY RECEIVED RESULTS OF 248 MG/DL AND 95 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. 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 549932

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR GLYBURIDE - 5MG 1/DAY| COUMADIN - DOSE UNK