BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2 TEST STRIPS

    MDR report key: 2000492 · Received January 31, 2011

    Report

    Report Number
    1826988-2011-00038
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 20, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HIS BLOOD GLUCOSE USING HIS BREEZE2 METER AND RECEIVED A READING OF "HI". HE RETESTED USING HIS ELITE METER AND RECEIVED A READING OF 105 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN HIS TEST STRIPS FOR EVAL. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZE2 TEST STRIPS NBW BAYER HEALTHCARE, LLC 1466A 1A5796AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK