BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1770955 · Received November 13, 2007

    Report

    Report Number
    1823260-2007-09883
    Event Type
    Malfunction
    Date Received
    November 13, 2007
    Date of Event
    November 5, 2007
    Report Date
    November 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF "HI" (> 600MG/DL), 220MG/DL, AND 220MG/DL ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES. CUSTOMER CHOSE TO INCREASE HIS ACTIVITY IN RESPONSE TO RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM 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 DEVICE - LFR LFR ROCHE DIAGNOSTICS 549532

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR NOVOLOG - SLIDING SCALE| LANTUS - 70UNITS/DAY