BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 3642811 · Received February 24, 2014

    Report

    Report Number
    1826988-2014-00040
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 30, 2014
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    JJX
    PMA / PMN Number
    K121087
    Removal / Correction Number
    Z-2482-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 HIGH OUT OF RANGE CONTROL RESULTS OF 198, 193, 189, 192 AND 195MG/DL ON THE CONTOUR NEXT USB 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. CONTROL SOLUTION IS TO BE RETURNED FOR EVALUATION. NEW STRIPS, METER AND CONTROL WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113970 CONTOUR NEXT QUALITY CONTROL MATERIAL JJX ASCENSIA DIABETES CARE US INC. 7314 2817

    Patients

    Seq Age Sex Outcome Treatment
    1