BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 3070039 · Received April 22, 2013

    Report

    Report Number
    1826988-2013-00172
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    JJX
    PMA / PMN Number
    K111268
    Removal / Correction Number
    Z-2482-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE CUSTOMER RECEIVED HIGH OUT OF RANGE CONTROL RESULTS OF 150 AND 184MG/DL ON HIS CONTOUR NEXT EZ METER. THE METER DID NOT AUTOMATICALLY MARK THEM AS A CONTROL TESTS, WHICH WILL BE DISPLAYED AS A BLOOD RESULTS WHEN ACCESSING THE METER'S MEMORY. NO ADVERSE EVENT WAS ALLEGED. THE ISSUE WAS RESOLVED DURING THE CALL. EXTRA STRIPS WERE SENT. NO PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171740 CONTOUR NEXT QUALITY CONTROL MATERIAL JJX ASCENSIA DIABETES CARE US INC. 7314 2493

    Patients

    Seq Age Sex Outcome Treatment
    1