BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2

    MDR report key: 3800608 · Received May 8, 2014

    Report

    Report Number
    1826988-2014-00157
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 208MG/DL ON THE BREEZE2 METER, RE-TESTED ON A CONTOUR NEXT EZ METER AND THE READING WAS OVER 600MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANTNO ADVERSE EVENT WAS ALLEGED.THE CUSTOMER RETURNED THE TEST STRIPS FOR EVALUATION.A REPLACEMENT KIT SENT TO THE CUSTOMER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278550 BREEZE2 BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 1466A 1A6480AA

    Patients

    Seq Age Sex Outcome Treatment
    1