BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1080611 · Received July 22, 2008

    Report

    Report Number
    1823260-2008-05667
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED BLOOD GLUCOSE RESULTS OF HI, WHICH ON THE ADVANTAGE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL, 235 MG/DL, AND 165 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. CUSTOMER REPORTER NO SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUEST WITH MADE FOR THE RETURN OF THE SYSTEM, 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 549949

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR METFORMIN 2000MG/DAY - 3 YEARS| ACTOS 30MG/DAY - 3 MONTHS