BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1140537 · Received August 28, 2008

    Report

    Report Number
    1823260-2008-06518
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ACCU-CHEK ADVANTAGE SYSTEM: 209MG/DL, 155MG/DL AND 73MG/DL. THE CUSTOMER FELT SHAKY, WEAK AND SWEATY. THE CUSTOMER RECEIVED AN ADDITIONAL SET OF RESULTS ON THE ACCU-CHEK ADVANTAGE SYSTEM: 200MG/DL, 150MG/DL AND 70MG/DL. HE FELT SHAKY WITH THE SECOND SET OF COMPARISONS. EACH SET OF COMPARISONS WERE OBTAINED WITHIN A TEN MINUTE TIMEFRAME. THE CUSTOMER ATE A CANDY BAR AFTER EACH EVENT AND FELT BETTER FOLLOWING TREATMENT. 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 DEVICE - LFR LFR ROCHE DIAGNOSTICS 550673

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR NOVOLIN| OMEGA FATTY ACID| METOPROLOL| RENIZODINE| FOLIC ACID| GEMFIBROZIL| NOVOLOG| GLYBURIDE| SIMOSTATIN| LISPO| METFORMIN| BABY ASPIRIN