BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 8137409 · Received December 6, 2018

    Report

    Report Number
    1810909-2018-00116
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Date of Event
    November 14, 2018
    Report Date
    November 15, 2018
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K160682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED TWO BOTTLES OF STRIPS AND A METER. THE TEST STRIPS RETURNED WERE LOT #S 7GPEG17B AND 7CPEB02A. THE RETURNED METER WAS TESTED WITH RETURNED STRIPS LOT # 7GPEG17B AND IN-HOUSE TEST STRIPS FROM THE SAME LOT. TWO OUT OF FIVE RESULTS FROM THE BOTTLE OF RETURNED TEST STRIPS WERE OUT OF THE EXPECTED RANGE, WHILE ALL READINGS FROM IN-HOUSE TEST STRIPS WERE WITHIN THE EXPECTED RANGE. THE RETURNED METER WAS ALSO TESTED WITH RETURNED STRIPS LOT # 7CPEB02A AND IN-HOUSE TEST STRIPS FROM THE SAME LOT. ALL RESULTS WERE WITHIN THE EXPECTED RANGE. THE RETURNED TEST STRIPS FROM LOT # 7GPEG17B WERE EVALUATED UNDER A MICROSCOPE, WHICH SHOWED DEBRIS AND LOOKED SLIGHTLY DAMAGED. IT IS POSSIBLE THAT OUT OF RANGE READINGS WERE OBTAINED BECAUSE THE RETURNED STRIPS WERE NOT STORED PROPERLY.

    Description of Event or Problem · 1

    (B)(6) CUSTOMER REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 364 AND 363 MG/DL ON A CONTOUR NEXT ONE METER. UPON RETESTING WITH A DIFFERENT METER, A READING OF 110 MG/DL WAS OBTAINED. THE DIFFERENCES BETWEEN THE READINGS FALLS IN "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS AND METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977626 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7GPEG17B

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR