BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2

    MDR report key: 2883717 · Received December 21, 2012

    Report

    Report Number
    1826988-2012-00673
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION IS NOT PROVIDED DUE TO PRIVACY LAWS. MODEL NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) RAN BLOOD GLUCOSE TESTS ON TWO BREEZE2 METERS. THE RESULTS WERE 235 AND 227MG/DL ON ONE METER AND 31MG/DL ON THE OTHER METER. 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 TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT PRODUCT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE2 BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7Y6229AA

    Patients

    Seq Age Sex Outcome Treatment
    1