BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2428015 · Received January 25, 2012

    Report

    Report Number
    1826988-2011-00776
    Event Type
    Malfunction
    Date Received
    January 25, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 28, 2011
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    LFR
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OPENED A NEW CARTON OF CONTOUR TEST STRIPS AND FOUND THE CAP OPEN ON THE BOTTLE OF STRIPS. 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 CONTOUR TEST STRIPS BLOOD GLUCOSE TEST STRIPS LFR BAYER HEALTHCARE LLC 7080G 1DC3C11

    Patients

    Seq Age Sex Outcome Treatment
    1