BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1214051 · Received October 23, 2008

    Report

    Report Number
    1826988-2008-01183
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THAT SHE OPENED THE CUSTOMER'S NEW CONTOUR KIT AND FOUND THE CAP OPEN ON THE SAMPLE BOTTLE OF THE TEST STRIPS. THE TEST STRIPS WERE NOT USED, SO NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS WERE TO BE RETURNED FOR EVALUATION, BUT THE CUSTOMER HAD ALREADY DISPOSED OF THEM. 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 9545C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK