BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK AVIVA

    MDR report key: 1082258 · Received July 24, 2008

    Report

    Report Number
    1823260-2008-05729
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INCIDENT OF HYPERGLYCEMIA REQUIRING PROFESSIONAL MEDICAL TREATMENT AT A TIME WHEN SHE WAS UNABLE TO USE HER AVIVA SYSTEM DUE TO ERROR WITHIN SPECIFICATIONS. THE DEVICE ERROR WAS RESOLVED THROUGH TROUBLESHOOTING WITH MANUFACTURER'S PRODUCT SUPPORT AGENT. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM AND A REPLACEMENT 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 50 YR Required Intervention HUMALOG 30/70 50 UNITS/DAY - 3 YEARS