BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2

    MDR report key: 4522698 · Received February 18, 2015

    Report

    Report Number
    1826988-2015-00062
    Event Type
    Malfunction
    Date Received
    February 18, 2015
    Date of Event
    January 23, 2015
    Report Date
    January 23, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTOUR TEST STRIPS WERE RETURNED FOR EVALUATION. STRIP INFORMATION WAS NOT PROVIDED IN THE INITIAL REPORT. LOT#3BJ3C02, EXP DATE 2/28/2015. MANUFACTURE DATE 02/01/2013. 510(K) K062058.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 246MG/DL ON THE BREEZE2, RE-TESTED ON A CONTOUR AND THE READING WAS 124MG/DL. 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 WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS AND METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116932 BREEZE2 BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 1465A 1A6612AA

    Patients

    Seq Age Sex Outcome Treatment
    1