BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2

    MDR report key: 1212676 · Received October 20, 2008

    Report

    Report Number
    1826988-2008-01225
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 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 SHE TESTED HER BLOOD GLUCOSE AND RECEIVED A READING OF 418 MG/DL USING HER BREEZE2 METER. SHE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 144 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DECLINED TO TROUBLESHOOT AND ENDED THE CALL. 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