BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 2946285 · Received February 6, 2013

    Report

    Report Number
    1826988-2013-00012
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR ASSISTANCE WITH HIS CONTOUR NEXT EZ METER AND STATED HE RAN A CONTROL TEST, BUT WHEN CHECKING THE METER MEMORY DURING THE CALL IT WAS DISCOVERED THERE WERE NO READINGS MARKED AS A CONTROL. THE CONTROL READING COULD POTENTIALLY BE INTERPRETED AS A BLOOD RESULT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS SATISFIED WITH TROUBLESHOOTING DURING THE CALL SO NO PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION. ADDITIONAL STRIPS WERE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50813 CONTOUR NEXT QUALITY CONTROL MATERIAL JJX ASCENSIA DIABETES CARE US INC. 7314 2490

    Patients

    Seq Age Sex Outcome Treatment
    1