BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE

    MDR report key: 713205 · Received May 5, 2006

    Report

    Report Number
    1826988-2006-00499
    Event Type
    Malfunction
    Date Received
    May 5, 2006
    Date of Event
    April 26, 2006
    Report Date
    April 26, 2006
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE RAN THREE NORMAL CONTROL TESTS AND HAD THE FOLLOWING RESULTS: H1, 247, AND 287 MG/DL.; THE NORMAL CONTROL RANGE IS 113-162 MG/DL.; THE CUSTOMER DID NOT ALLEGE ANY ADVERSE EVENTS. THE METER AND THE STRIPS ARE TO BE RETURNED FOR EVALUATION, AND NEW PRODUCTS WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN