BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA METER

    MDR report key: 1780631 · Received September 27, 2007

    Report

    Report Number
    1823260-2007-08442
    Event Type
    Malfunction
    Date Received
    September 27, 2007
    Date of Event
    September 11, 2007
    Report Date
    September 27, 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

    THE CUSTOMER'S NIECE REPORTED THAT THE CUSTOMER OBTAINED UNDOSED RESULTS ON HER ACCU-CHEK AVIVA SYSTEM. NO AVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR HUMULIN 70/30 - 30 UNITS/DAY - 8 YRS| ANTIBIOTIC 4 PILLS/DAY 1 MONTH (THERAPY COMPLETED)