BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA

    MDR report key: 1770600 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09324
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    October 10, 2007
    Report Date
    October 25, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED BLOOD GLUCOSE RESULT OF 116 MG/DL IMMEDIATELY AFTER THE TEST STRIP WAS INSERTED IN THE METER ON THE AVIVA SYSTEM. THE CUSTOMER HAD NOT YET APPLIED BLOOD TO THE STRIP. NO SYMPTOMS, TREATMENT OR ACTIONS WERE REPORTED. NO SERIOUS ADVERSE EVENT WAS REPORTED IN RELATION TO THE ALLEGED MALFUNCTION. SUSPECT PRODUCT IS UNAVAILABLE FOR RETURN; REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR