BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 5113172 · Received September 30, 2015

    Report

    Report Number
    1826988-2015-00497
    Event Type
    Malfunction
    Date Received
    September 30, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 10, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A PHARMACIST STATED THE CUSTOMER'S CONTOUR WAS NOT STORING ALL OF THE BLOOD RESULTS.. NO ADVERSE EVENT ALLEGED. THE ADVOCATE WAS ASKED TO RETURN THE METER FOR INVESTIGATION. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644583 CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 9676

    Patients

    Seq Age Sex Outcome Treatment
    1