BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2 TEST STRIPS

    MDR report key: 1850220 · Received September 22, 2010

    Report

    Report Number
    1826988-2010-00656
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 15, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062347
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 436 MG/DL FROM HER BREEZE2 METER AND A READING OF 203 MG/DL FROM ANOTHER 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 ADVOCATE WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT 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 880844 1A5553AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK