BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1061540 · Received June 17, 2008

    Report

    Report Number
    1823260-2008-04785
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY OBTAINED A 330 MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM IN COMPARISON TO THE PROFESSIONAL METER RESULT OF 152 MG/DL. THE RESULTS WERE OBTAINED WITHIN A TEN MINUTE TIMEFRAME. NO REPORTED ACTIONS TAKEN. 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 550054

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR AVANDIA 4MG/DAY - 4 YEARS| GLIPIZIDE 10MG/DAY - 8 YEARS