BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREZE2

    MDR report key: 4102916 · Received September 19, 2014

    Report

    Report Number
    1826988-2014-00320
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 28, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED BLOOD GLUCOSE READINGS OF 160, AND OVER 200MG/DL ON THE BREEZE2 METER, RE-TESTED ON A DIFFERENT METER AND THE READINGS WERE 25 AND 96MG/DL. THE DIFFERENCES BETWEEN THE READINGS FALL IN THE "C" AND "D" ZONES OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER RETURNED THE TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585150 BREZE2 BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 1466A 1A6498AA

    Patients

    Seq Age Sex Outcome Treatment
    1