BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE2 TEST STRIPS (50)

    MDR report key: 1577136 · Received December 28, 2009

    Report

    Report Number
    1826988-2009-01079
    Event Type
    Malfunction
    Date Received
    December 28, 2009
    Date of Event
    December 4, 2009
    Report Date
    December 4, 2009
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED BLOOD GLUCOSE READINGS OF 230, 240, 257 AND 310 MG/DL FROM HIS BREEZE2 METER AND A READING OF 120 MG/DL FROM ANOTHER BREEZE2 METER. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER 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 (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 1467A 1A5547AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK