BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2 TEST STRIPS

    MDR report key: 2213857 · Received August 4, 2011

    Report

    Report Number
    1826988-2011-00454
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 16, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE CUSTOMER'S BREEZE2 METER GAVE BLOOD GLUCOSE READINGS OF 210 AND 275 MG/DL, WHILE ANOTHER METER READ 105 MG/DL. 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 ALSO PERFORMED CONTROL TESTS DURING THE CALL AND RECEIVED RESULTS OF 168 AND 194 MG/DL. THE NORMAL CONTROL RANGE WAS 99-127 MG/DL. THE ADVOCATE WAS ADVISED TO RETURN THE TEST STRIPS 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
    1 BREEZE2 TEST STRIPS NBW BAYER HEALTHCARE, LLC 1465A 1A5886AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK