BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1234098 · Received November 4, 2008

    Report

    Report Number
    1823260-2008-08162
    Event Type
    Malfunction
    Date Received
    November 4, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 4, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    UDI-DI
    03000141001
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY OBTAINED A 300MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM IN COMPARISON TO THE PROFESSIONAL METER RESULT OF 148MG/DL. THE RESULTS WERE OBTAINED WITHIN A TEN MIN TIMEFRAME. 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-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550537 03000141001

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR