BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1061017 · Received June 12, 2008

    Report

    Report Number
    1826988-2008-00609
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 13, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS VISUALLY IMPAIRED AND UNABLE TO PROVIDE REAGENT INFORMATION, SO METER INFORMATION WAS PROVIDED INSTEAD.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE RECEIVED A NEW CARTON OF TEST STRIPS AND FOUND THE CAP OPEN ON THE BOTTLE WHEN SHE OPENED THE CARTON. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION, AS EXPOSURE TO MOISTURE CAN CAUSE HIGH TEST RESULTS. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK