BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1022651 · Received March 31, 2008

    Report

    Report Number
    1823260-2008-02895
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE CUSTOMER OBTAINED A 101MG/DL AND 204MG/DL BLOOD GLUCOSE COMPARISON ON THE ACCU-CHEK ADVANTAGE SYSTEM. THE RESULTS WERE OBTAINED WITHIN A 10 MINUTE TIMEFRAME. NO REPORTED ACTIONS TAKEN BASED ON THE BLOOD GLUCOSE RESULTS. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    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 550055

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR METFORMIN 2000MG/DAY| "DECODRIN" 40 GRAMS/DAY 30 YEARS