BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1060828 · Received June 16, 2008

    Report

    Report Number
    1823260-2008-04761
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 630MG/DL, 239MG/DL AND 78MG/DL. CUSTOMER WAS USING EXPIRED STRIPS. NO QUALITY CONTROLS WERE RUN. 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 549222

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR GLIPIZIDE 10MG 2X/DAY 1 YEAR| NOVOLIN N 15 UNITS 2X/DAY 1 YEAR