BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHCK COMFORT CURVE TEST STRIPS

    MDR report key: 1070498 · Received July 7, 2008

    Report

    Report Number
    1823260-2008-05225
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 14, 2008
    Report Date
    July 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A BLOOD GLUCOSE RESULT OF 358MG/DL WITH THE OLD ACCU-CHEK COMFORT CURVE STRIPS AND BLOOD GLUCOSE RESULT OF 87MG/DL WITH THE NEW ACCU-CHEK COMFORT CURVE STRIPS. THE RESULTS WERE OBTAINED WITHIN A TEN MINUTE TIMEFRAME. THE STRIPS HAD THE SAME LOT NUMBER. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. 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-CHCK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS-LFR LFR ROCHE DIAGNOSTICS 550095

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR UNK NAME OF MEDICATION 1000MG/DAY-6 MONTHS