BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2

    MDR report key: 4102819 · Received September 19, 2014

    Report

    Report Number
    1826988-2014-00315
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 30, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SECOND LOT# OF BREEZE2 STRIPS, WHICH COULD HAVE BEEN USED IN THE SECOND METER INVOLVED, WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HIS BLOOD GLUCOSE USING 2 BREEZE2 METERS AND RECEIVED READINGS OF 180 AND 80MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS AND A NEW METER WERE SENT TO THE CUSTOMER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583995 BREEZE2 BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 1467A 1A6565AA

    Patients

    Seq Age Sex Outcome Treatment
    1