BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2

    MDR report key: 955655 · Received November 28, 2007

    Report

    Report Number
    1826988-2007-00714
    Event Type
    Malfunction
    Date Received
    November 28, 2007
    Date of Event
    October 29, 2007
    Report Date
    October 29, 2007
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HIS BREEZE2 METER. HE STATED, THAT HE WANTED TO CHANGE THE UNITS OF MEASURE FROM MMOL/L TO MG/DL. THE CUSTOMER WAS TOLD THAT THE UNITS OF MEASURE ARE LOCKED ON THE BREEZE2 METER AND CANNOT BE CHANGED. WHEN THE CUSTOMER SERVICE REPRESENTATIVE ATTEMPTED TO GET MORE INFORMATION, THE CUSTOMER ENDED THE CALL. ATTEMPTS TO CALL THE CUSTOMER BACK WERE NOT SUCCESSFUL SINCE THE PHONE NUMBER HE PROVIDED WAS NO LONGER IN SERVICE. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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 YR