BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIP

    MDR report key: 1032037 · Received April 21, 2008

    Report

    Report Number
    1823260-2008-03396
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S DAUGHTER REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE AVIVA SYS WITH RESULTS OF 171MG/DL, 65MG/DL, 153MG/DL AND 58MG/DL. NO QUALITY CONTROLS WERE RUN. NO ADVERSE EVENT REPORT. 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 STRIP BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 300749

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR NOVOLIN 15 UNITS 2X/DAY - 5 YEARS