BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1083328 · Received July 25, 2008

    Report

    Report Number
    1823260-2008-05784
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    September 18, 2007
    Report Date
    July 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 120MG/DL AND 230MG/DL ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES. NO ACTION TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER STRIPS ARE UNAVAILABLE FOR RETURN.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NOVOLOG - 4 YRS 55 UNITS/DAY| METFORMIN - 3 YEARS 1000MG/DAY