BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1770964 · Received November 13, 2007

    Report

    Report Number
    1823260-2007-09881
    Event Type
    Malfunction
    Date Received
    November 13, 2007
    Date of Event
    November 1, 2007
    Report Date
    November 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    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 OBTAINED RESULTS OF 32MG/DL AND 74MG/DL ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES. AN ADDITIONAL COMPARISON WAS REPORTED WITH RESULTS OF 265MG/DL, 161MG/DL, AND 115MG/DL ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES. NO ACTION TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM 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 TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549730

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR GLYBURIDE - 6 MONTHS - 5MG/DAY| METFORMIN - 6 MONTHS - 2000MG/DAY