BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE 2

    MDR report key: 5113101 · Received September 30, 2015

    Report

    Report Number
    1826988-2015-00488
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    September 8, 2015
    Report Date
    September 8, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 488MG/DL ON THE BREEZE2. HE RETESTED ON A DIFFERENT METER AND THE READING WAS 184MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THERE WAS NO EVIDENCE OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS AND METER WERE SENT TO HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645176 BREEZE 2 BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 1465A 1A6714AA

    Patients

    Seq Age Sex Outcome Treatment
    1