BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1772060 · Received November 1, 2007

    Report

    Report Number
    1823260-2007-09519
    Event Type
    Malfunction
    Date Received
    November 1, 2007
    Date of Event
    October 22, 2007
    Report Date
    November 1, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 237 MG/DL, 190 MG/DL, 127 MG/DL, AND 97 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE AVIVA SYSTEM. REPORTER INDICATED SHE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. REPORTER ALSO ALLEGED THAT THE RESULTS OF 237 MG/DL AND 97 MG/DL WERE MISSING FROM THE DEVICE'S MEMORY. NO ACTIONS OR TREATMENTS WERE REPORTED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 300690

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR BYETTA - 10 UNITS TWICE DAILY| LANTUS - 2 YEARS - 30 UNITS ONCE DAILY