BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2

    MDR report key: 1111907 · Received August 8, 2008

    Report

    Report Number
    1826988-2008-00845
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 11, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE TESTED HIS BLOOD GLUCOSE AND RECEIVED A READING OF 40 MG/DL USING HIS BREEZE2 METER. HE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 140 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALL IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WERE ALLEGED. THE CUSTOMER DID NOT HAVE ANY TEST STRIPS, SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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