BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE

    MDR report key: 920094 · Received September 20, 2007

    Report

    Report Number
    1826988-2007-00461
    Event Type
    Malfunction
    Date Received
    September 20, 2007
    Date of Event
    August 21, 2007
    Report Date
    August 21, 2007
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE PERFORMED A CONTROL TEST AND RECEIVED A RESULT OF 66 MG/DL. THE NORMAL CONTROL RANGE WAS 113-163 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. TROUBLESHOOTING SHOWED THE SYSTEM TO BE OPERATING AS DESIGNED. NO PRODUCT WILL BE RETURNED FOR EVALUATION. A NEW BREEZE 2 METER WAS SENT TO THE CUSTOMER.

    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 YR