BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1772053 · Received November 1, 2007

    Report

    Report Number
    1823260-2007-09529
    Event Type
    Malfunction
    Date Received
    November 1, 2007
    Date of Event
    October 10, 2007
    Report Date
    November 1, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED SEVERAL DISCREPANT RESULTS WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. TEST RESULTS WERE 249 MG/DL AND 120 MG/DL; 42 MG/DL AND 148 MG/DL; 148 MG/DL AND 56 MG/DL; 56 MG/DL AND 327 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULT. 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 549915

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR GLIPIZIDE - 5 MG ONCE DAILY - 2-3 YEARS| METFORMIN - 500 MG TWICE A DAY - 2-3 YEARS