BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 6099361 · Received November 14, 2016

    Report

    Report Number
    1826988-2016-00418
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 26, 2016
    Report Date
    October 26, 2016
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CALL ENDED BEFORE THE CUSTOMER'S PERSONAL INFORMATION (A1, E1) OR PRODUCT INFORMATION (D4) COULD BE OBTAINED. IT'S NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE (H4) WITHOUT THE PRODUCT INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED HIGH OUT OF RANGE CONTROL READINGS OF 341 AND 326MG/DL ON THE CONTOUR NEXT EZ METER. WHILE CHECKING THE MEMORY OF THE METER IT WAS DISCOVERED THAT THE READINGS WERE NOT AUTOMATICALLY MARKED AS CONTROL TESTS, WHICH WILL BE DISPLAYED AS BLOOD RESULTS WHEN ACCESSING THE METER'S MEMORY. NO ADVERSE EVENT WAS ALLEGED. THE CONTROL SOLUTION WAS NOT EXPECTED TO BE RETUNED. NO PRODUCT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749583 CONTOUR NEXT QUALITY CONTROL MATERIAL JJX ASCENSIA DIABETES CARE US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1