BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2

    MDR report key: 1001163 · Received February 15, 2008

    Report

    Report Number
    1826988-2008-00196
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 30, 2008
    Report Date
    January 30, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED ABOUT A CONTROL TEST RESULT THAT SHE HAD RECEIVED. WHILE TROUBLESHOOTING, IT WAS DISCOVERED HER METER 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