BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACENSIA BREEZE

    MDR report key: 748889 · Received July 27, 2005

    Report

    Report Number
    MW1036142
    Event Type
    Injury
    Date Received
    July 27, 2005
    Date of Event
    October 1, 2004
    Report Date
    July 27, 2005
    Manufacturer
    BAYER CORP
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEVICE GIVES INACCURATE READING. IT IS DECEPTIVE. MANUFACTURER WILL NOT DO ANYTHING ABOUT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACENSIA BREEZE BLOOD GLUCOSE MONITOR NBW BAYER CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening