BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2

    MDR report key: 3811970 · Received May 15, 2014

    Report

    Report Number
    1826988-2014-00165
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 21, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED BLOOD GLUCOSE READINGS OF 313, 317 AND 308MG/DL ON THE BREEZE2 METER, WAS RE-TESTED ON THE DOCTOR'S METER AND THE READINGS WERE 106 AND 107MG/DL. THE DIFFERENCES BETWEEN THE READINGS FALL IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES 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
    291834 BREEZE2 BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 1465A 1A6521BA

    Patients

    Seq Age Sex Outcome Treatment
    1