BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2

    MDR report key: 1163651 · Received September 9, 2008

    Report

    Report Number
    1826988-2008-01002
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HER BREEZE2 METER BECAUSE SHE NOTICED A PROBLEM WITH THE METER DISPLAY. WHILE TROUBLESHOOTING, IT WAS CONFIRMED THE METER DISPLAY WAS MISSING SEGMENTS. THE CUSTOMER WAS NOT AWARE OF THE MISSING SEGMENTS, BUT NO ADVERSE EVENTS WERE ALLEGED. THE METER IS TO BE RETURNED FOR EVALUATION. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA BREEZE2 BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 1440 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK