BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2994105 · Received March 8, 2013

    Report

    Report Number
    1826988-2013-00073
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    JJX
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED HIGH OUT OF RANGE CONTROL RESULTS OF 346MG/DL AND 260MG/DL ON THE CONTOUR METER. THE METER DID NOT AUTOMATICALLY MARK THEM AS A CONTROL TESTS, WHICH WILL BE DISPLAYED AS BLOOD RESULTS WHEN ACCESSING THE METER'S MEMORY. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS SATISFIED WITH THE TROUBLESHOOTING DURING THE CALL. PRODUCT WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99008 CONTOUR QUALITY CONTROL MATERIAL JJX BAYER HEALTHCARE LLC 7109B 2343

    Patients

    Seq Age Sex Outcome Treatment
    1