BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2 TEST STRIPS

    MDR report key: 1850199 · Received September 22, 2010

    Report

    Report Number
    1826988-2010-00641
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 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
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 228 MG/DL FROM HIS BREEZE2 METER AND A READING OF 40 MG/DL FROM HIS CONTOUR METER. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER ALSO PERFORMED CONTROL TESTS WHILE TROUBLESHOOTING AND RECEIVED RESULTS OF 219 AND 229 MG/DL. THE NORMAL CONTROL RANGE WAS 94-129 MG/DL. THE CUSTOMER 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 880844 1A5636AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK