BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 3541478 · Received December 30, 2013

    Report

    Report Number
    1826988-2013-00619
    Event Type
    Malfunction
    Date Received
    December 30, 2013
    Date of Event
    December 3, 2013
    Report Date
    December 3, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL# WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE TEST STRIPS WERE RETURNED FOR EVALUATION AND CONFIRMED FOR OPEN CAP BUT THE PRODUCT GAVE SATISFACTOY PERFORMANCE.

    Description of Event or Problem · 1

    UPON PACKING INSPECTION AT BAYER HEALTHCARE IN (B)(6), IT WAS DISCOVERED, AFTER OPEING THE BOX, THE CAP OF A NEW BOTTLE OF CONTOUR TEST STRIPS WAS ALREADY OPENED. RETENTION STRIP PACKAGE WAS OPENED AND THE BOTTLE CAP WAS CLOSED.THE BOTTLE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679307 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 3GJ3F03

    Patients

    Seq Age Sex Outcome Treatment
    1