BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1011690 · Received March 10, 2008

    Report

    Report Number
    1823260-2008-02255
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 10, 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 224, 463, AND 559 MG/DL WHEN ALL TESTS WERE PERFORMED WITH IN 5 MINUTES ON THE ADVANTAGE SYSTEM. REPORTER STATED HE WAS NOT EXPERIENCING ANY HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTED 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 DEVICE- LFR LFR ROCHE DIAGNOSTICS 550055

    Patients

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