BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1063799 · Received June 19, 2008

    Report

    Report Number
    1823260-2008-04864
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE ADVANTAGE SYSTEM WITH RESULTS OF 180 - 190 MG/DL AND 101 - 104 MG/DL. AGENT WAS "NOT ABLE TO GET THE EXACT READINGS BECAUSE CUSTOMER DIDN'T WRITE DOWN THE HIGHER OF THE TWO NUMBERS" AND THE TIME AND DATE WERE NOT SET IN THE METER TO BE ABLE TO RETRIEVE THE EXACT NUMBERS. NO QUALITY CONTROLS WERE RUN DURING THE CALL. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT, AND A 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 550513

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR METFORMIN 3-4 MONTHS| NPH 25 YRS