BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2

    MDR report key: 1030417 · Received April 15, 2008

    Report

    Report Number
    1826988-2008-00440
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    April 3, 2008
    Report Date
    April 3, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HER METER. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 48 MG/DL. THE NORMAL CONTROL RANGE WAS 92-125 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE 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