BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2

    MDR report key: 1923876 · Received December 8, 2010

    Report

    Report Number
    1826988-2010-00816
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HER BLOOD GLUCOSE AND RECEIVED A READING OF 350 MG/DL FROM HER BREEZE2 METER AND A READING OF 130 MG/DL FROM HER BREEZE METER. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER DID NOT HAVE ANY TEST STRIPS LEFT, SO NO PRODUCT WILL BE RETURNED. THE METER WAS REPLACED AT THE CUSTOMER'S INSISTENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE2 NBW BAYER HEALTHCARE, LLC 9570A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK