BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE (US)

    MDR report key: 1001241 · Received February 15, 2008

    Report

    Report Number
    1826988-2008-00221
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 6, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER PERFORMED COMPARISON TESTS USING HER BREEZE, BREEZE2, AND CONTOUR METERS. THE BREEZE METER READ 259 MG/DL, WHILE THE CONTOUR METER READ 112 MG/DL. THE CUSTOMER STATED THAT SHE WAS CONFIDENT WITH HER CONTOUR READING. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DID NOT HAVE ANY TESTING SUPPLIES LEFT FOR THE BREEZE METER, SO TROUBLESHOOTING WAS NOT POSSIBLE. NO PRODUCT WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA BREEZE (US) BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 6117 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK