BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE (US)

    MDR report key: 1031873 · Received April 15, 2008

    Report

    Report Number
    1826988-2008-00372
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE TESTED HIS BLOOD GLUCOSE USING HIS BREEZE METER AND RECEIVED READINGS OF "HI" AND "LO". HE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 163MG/DL. THE DIFFERENCE BETWEEN THE METER READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER'S METER AND TEST STRIPS ARE TO BE RETURNED FOR EVAL. REPLACEMENT PRODUCTS WERE SENT TO THE CUSTOMER.

    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