BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE (TH)

    MDR report key: 823469 · Received January 31, 2007

    Report

    Report Number
    1826988-2007-00058
    Event Type
    Malfunction
    Date Received
    January 31, 2007
    Date of Event
    January 15, 2007
    Report Date
    January 15, 2007
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HIS METER. WHILE TROUBLESHOOTING, THE CUSTOMER PERFORMED NORMAL CONTROL TESTS AND RECEIVED RESULT OF 72 MG/DL. THE NORMAL CONTROL RANGE WAS 113-162 MG/DL. THE CUSTOMER DID NOT ALLEGE ANY ADVERSE EVENTS. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION, AND REPLACEMENT TEST STRIPS WILL BE SENT.

    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 YR