BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 4906251 · Received July 10, 2015

    Report

    Report Number
    1826988-2015-00325
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 7, 2015
    Report Date
    June 15, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION IS NOT PROVIDED DUE TO PRIVACY LAWS. THE MODEL# WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    CORRECTIONS: THE NAME OF THE METER IN DESCRIPTION OF EVENT OR PROBLEM, SHOULD BE CONTOUR NEXT LINK 2.4. THE PRODUCT DOES NOT HAVE 510(K)#. IT IS AWAITING PMA.

    Additional Manufacturer Narrative · 1

    THE RETURNED STRIPS WERE EVALUATED. THEY GAVE AN AVE OF 201MG/DL HIGH OUT OF SPEC. WITH CONTROL, AND AN AVE OF 131MG/DL HIGH OUT OF SPEC WITH BLOOD. RETENTION REAGENT GAVE SATISFACTORY PERFORMANCE.

    Description of Event or Problem · 1

    A (B)(6) CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF >6.0G/L ON THE CONTOUR NEXT LINK, RETESTED ON A DIFFERENT METER AND RECEIVED 1.76G/L. ON (B)(6) 2015 HE RECEIVED A READING OF 4.88G/L ON THE CONTOUR NEXT LINK, RETESTED ON ANOTHER METER AND RECEIVED 1.95G/L. THE DIFFERENCES BETWEEN THE READINGS FELL IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE TEST STRIPS WERE EXPECTED TO BE RETURNED FOR EVALUATION. REPLACEMENT PRODUCT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450029 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 4MFEB06

    Patients

    Seq Age Sex Outcome Treatment
    1