BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1022644 · Received March 31, 2008

    Report

    Report Number
    1823260-2008-02876
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 2, 2008
    Report Date
    March 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 114, 138, AND 435 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN LESS THAN 5 MINUTES OF EACH OTHER ON THE ADVANTAGE SYSTEM. REPORTER STATED HE WAS NOT EXPERIENCING ANY HYPERGLYCEMIC OR HYPOGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTEDLY TAKEN OR TREATMENT WAS RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 549943

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR METFORMIN - 1000 MG TWICE DAILY| GLYCANIDIDE - 30 MG ONCE DAILY| ACTOS - 30 MG ONCE DAILY