BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA BREEZE2

    MDR report key: 1163653 · Received September 9, 2008

    Report

    Report Number
    1826988-2008-01000
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA LAB WAS NOT ABLE TO CONFORM THE LOW RESULT COMPLAINT. THEY DID FIND THE RETURNED METER TO HAVE A SINGLE ABRASION IN THE SENSOR PRESENTATION AREA OF THE METER. THE ABRASION OCCURS WHEN ONE OF THE CONTACTS THAT MUST TOUCH THE SENSOR IS LIFTED. THIS CAUSES THE METER TO NOT COUNTDOWN.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HER BREEZE2 METER. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 71 MG/DL. THE NORMAL CONTROL RANGE WAS 114-165 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS WERE TO BE RETURNED FOR EVALUATION, BUT THE QA LAB ONLY RECEIVED THE METER. REPLACEMENT PRODUCTS WERE SENT TO THE CUSTOMER.

    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