BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 4140737 · Received October 3, 2014

    Report

    Report Number
    1826988-2014-00344
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 13, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED AND STATED THEY TESTED WITH BLOOD ON THE CONTOUR METER AND THE RESULT WAS MARKED AS A CONTROL TEST, WHICH WILL BE DISPLAYED AS A CONTROL RESULT WHEN ACCESSING THE METER¿S MEMORY. NO ADVERSE EVENT WAS ALLEGED. NEW METER AND STRIPS SENT TO CUSTOMER. STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619998 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7097C 4BJ3D03A

    Patients

    Seq Age Sex Outcome Treatment
    1