BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1163666 · Received September 9, 2008

    Report

    Report Number
    1826988-2008-01009
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE OPENED A NEW CARTON OF TEST STRIPS AND FOUND THE CAP OPEN ON THE BOTTLE OF STRIPS. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER WAS ASKED TO RETURN THE TEST STRIPS FOR EVALUATION, AS EXPOSURE TO MOISTURE CAN CAUSE HIGH RESULTS, BUT HE REFUSED. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 7151B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK