BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE (US)

    MDR report key: 1001151 · Received February 15, 2008

    Report

    Report Number
    1826988-2008-00179
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 22, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER SERIAL NUMBER PROVIDED BY THE CUSTOMER WAS NOT CORRECT, SO IT WAS NOT POSSIBLE TO DETERMINE A MANUFACTURE DATE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT SHE PERFORMED A CONTROL TEST AND RECEIVED A RESULT OF 20 MG/DL. THE NORMAL CONTROL RANGE WAS NOT PROVIDED, BUT SHOULD BE AROUND 115-165 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DID NOT HAVE ANY TEST STRIPS LEFT, SO NO PRODUCT WILL BE RETURNED FOR EVALUATION. A NEW BREEZE2 METER KIT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA BREEZE (US) BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 6117 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK