BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2

    MDR report key: 1923878 · Received December 8, 2010

    Report

    Report Number
    1826988-2010-00828
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 29, 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
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REFUSED TO PROVIDE HER TELEPHONE NUMBER.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF "HI" FROM HER BREEZE2 METER AND READINGS OF 128 AND 86 MG/DL FROM ANOTHER METER. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" AND "D" ZONES OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER DECLINED TO RETURN ANY PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE2 NBW BAYER HEALTHCARE, LLC 1440C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK