BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2

    MDR report key: 4091264 · Received September 16, 2014

    Report

    Report Number
    1826988-2014-00307
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 23, 2014
    Report Date
    August 23, 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 170MG/DL ON THE BREEZE2 METER, RE-TESTED ON A DIFFERENT METER AND THE READING WAS 94MG/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 STRIP INFORMATION WAS NOT PROVIDED BUT STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATION. A NEW METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573437 BREEZE2 BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 9590

    Patients

    Seq Age Sex Outcome Treatment
    1