BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1781027 · Received July 26, 2007

    Report

    Report Number
    1823260-2007-06536
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Date of Event
    July 16, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED BLOOD GLUCOSE RESULTS OF 371 MG/DL, 185 MG/DL, 164 MG/DL, AND 193 MG/DL OBTAINED ON THE ADVANTAGE SYSTEM WITHIN 9 MINUTES. REPORTER STATED CUSTOMER WAS FEELING NO SYMPTOMS AND NO TREATMENT/ACTION WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 549739

    Patients

    Seq Age Sex Outcome Treatment
    1 NA GLYBURIDE/METFORMIN - TWICE DAILY