BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2

    MDR report key: 1021827 · Received March 27, 2008

    Report

    Report Number
    1826988-2008-00324
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    January 28, 2008
    Report Date
    January 28, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A PHARMACIST CALLED ON BEHALF OF A CUSTOMER. HE STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS TESTED USING HIS BREEZE2 METER AND HIS DR'S METER. THE CUSTOMER'S BREEZE2 READ IN THE 400'S (MG/DL), WHILE THE DR'S METER READ IN THE 100'S (MG/DL). THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE PHARMACIST IS TO RETURN THE CUSTOMER'S TEST STRIPS AND METER FOR EVAL. THE PHARMACIST GAVE THE CUSTOMER A NEW CONTOUR METER KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA BREEZE2 BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 1440 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK