BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE (TH)

    MDR report key: 1120984 · Received August 13, 2008

    Report

    Report Number
    1826988-2008-00866
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAD HIS BLOOD GLUCOSE TESTED WHILE AT THE HOSPITAL AND HIS READING WAS 250 MG/DL. HE ALSO TESTED USING HIS BREEZE2 METER AND RECEIVED A READING OF 76 MG/DL. 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 DECLINED TO TROUBLESHOOT HIS BREEZE2 SYSTEM. THE METER WILL BE REPLACED AT HIS INSISTENCE. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK