BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1761146 · Received July 19, 2007

    Report

    Report Number
    1823260-2007-06311
    Event Type
    Malfunction
    Date Received
    July 19, 2007
    Date of Event
    July 5, 2007
    Report Date
    July 19, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED GETTING A 244 MG/DL AND A 113 MG/DL ON HIS ADVANTAGE SYSTEM WITHIN 5 MINUTES. THE STRIPS USED WERE FROM TWO DIFFERENT VIALS OF STRIPS FROM THE SAME LOT NUMBER AND WITH THE SAME EXPIRATION DATE. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    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 549608

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR AVANDIA 4 MG TWICE DAILY| GLYPIZIDE 10 MG TWICE DAILY| METFORMIN TWICE DAILY