BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2

    MDR report key: 913159 · Received September 14, 2007

    Report

    Report Number
    1826988-2007-00450
    Event Type
    Malfunction
    Date Received
    September 14, 2007
    Date of Event
    August 20, 2007
    Report Date
    August 20, 2007
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED IN FOR HELP WITH HER METER. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED A CONTROL TEST RESULT OF "LO". THE NORMAL CONTROL RANGE WAS 113-163 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. FURTHER TROUBLESHOOTING SHOWED THE SYSTEM TO BE OPERATING AS DESIGNED. 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 YR