BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 4122637 · Received September 26, 2014

    Report

    Report Number
    1826988-2014-00333
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    JJX
    PMA / PMN Number
    K121190
    Removal / Correction Number
    Z-2482-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEE REMEDIAL ACTION AND CORRECTION/REMOVAL REPORTING NUMBER. THIS INFORMATION WAS NOT PROVIDED IN THE INITIAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A HIGH OUT OF RANGE CONTROL RESULT OF 407MG/DL ON THE CONTOUR NEXT METER. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, WHICH WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER¿S MEMORY. NO ADVERSE EVENT WAS ALLEGED. A NEW METER WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602082 CONTOUR NEXT QUALITY CONTROL MATERIAL JJX ASCENSIA DIABETES CARE US INC. 7314 2921

    Patients

    Seq Age Sex Outcome Treatment
    1