BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1771158 · Received February 5, 2008

    Report

    Report Number
    1823260-2008-01236
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 30, 2008
    Report Date
    February 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE ADVANTAGE SYSTEM WITH RESULTS OF: 40 MG/DL AND 181 MG/DL, 40 MG/DL AND 173 MG/DL, 40 MG/DL AND 188 MG/DL. 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 549628

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR LISINOPRIL, 20 MG DAY - 9 YEARS| METFORMIN, 500 MG IN AM - 5 YEARS| METFORMIN, 1000 MG IN PM - 5 YEARS| BABY ASPIRIN, 81 MG DAY - 9 YEARS| SIMVASTATIN, 20 MG DAY - 9 YEARS| GLYBURIDE, 5 MG/3X DAY - 7 YEARS| FINASTERIDE, 5 MG DAY - 1 YEAR