BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1171422 · Received September 17, 2008

    Report

    Report Number
    1823260-2008-06935
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    September 13, 2008
    Report Date
    September 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    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 AVIVA SYSTEM WITH RESULTS OF 515MG/DL, 248MG/DL AND 219MG/DL. LEVEL 1 QUALITY CONTROL WAS RUN AND IN RANGE. 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 AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS-LFR LFR ROCHE DIAGNOSTICS 300916

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR GLIPIZIDE| SIMVASTATIN| AMITRIPTYLINE - 6 YEARS| METFORMIN - 6 YEARS| ACTOS| GABAPENTIN - 6 YEARS| LISINOPRIL