BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1060072 · Received June 12, 2008

    Report

    Report Number
    1823260-2008-04686
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    January 2, 2008
    Report Date
    June 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A 36MG/DL AND 122MG/DL BLOOD GLUCOSE COMPARISON ON THE ACCU-CHEK ADVANTAGE SYSTEM. THE TEST RESULTS WERE OBTAINED WITHIN 10 MINUTE TIMEFRAME. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED. THE CUSTOMER STATES THAT THE STRIPS USED TO OBTAIN THE BLOOD GLUCOSE COMPARISON HAVE BEEN DEPLETED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR METFORMIN 1000MG/DAY - 1YR