BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2

    MDR report key: 1163676 · Received September 9, 2008

    Report

    Report Number
    1826988-2008-01023
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 24, 2008
    Report Date
    August 24, 2008
    Manufacturer
    BAYER HEALTHCARE LLC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HER BLOOD GLUCOSE RESULTS HAD BEEN HIGHER THAN USUAL. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 184 MG/DL. THE NORMAL CONTROL RANGE WAS NOT PROVIDED, BUT SHOULD BE AROUND 90-123 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER USED THE LAST OF HER TEST STRIPS WHILE TROUBLESHOOTING, SO 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