BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 8953608 · Received September 2, 2019

    Report

    Report Number
    1810909-2019-00384
    Event Type
    Malfunction
    Date Received
    September 2, 2019
    Date of Event
    August 5, 2019
    Report Date
    August 8, 2019
    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 · 0

    THE CUSTOMER RETURNED THE SUSPECTED CONTOUR NEXT ONE METER, WHILE THE CONTOUR NEXT TEST STRIPS (LOT # 8LPEF03A) RETURNED WAS DIFFERENT FROM THE SUSPECTED LOT OF TEST STRIPS I.E. LOT # 8BPEG18A. AN IN-HOUSE TESTING WAS PERFORMED USING THE RETURNED METER AND RETURNED TEST STRIPS. ADDITIONALLY, TESTING WAS ALSO PERFORMED USING THE RETURNED METER AND IN-HOUSE TEST STRIPS FROM LOT # 8BPEG18A. ALL READINGS WERE WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION IS NOT PROVIDED DUE TO PRIVACY LAWS. NO INFORMATION WAS CAPTURED AS THE CUSTOMER'S AGE AND WEIGHT WERE NOT PROVIDED. THE MODEL # WAS NOT PROVIDED. THIS EVENT IS RELATED TO MDRS 1810909-2019-00383, 1810909-2019-00385, 1810909-2019-00386, 1810909-2019-00387, AND 1810909-2019-00388.

    Description of Event or Problem · 1

    AN ADVOCATE FROM (B)(6) REPORTED THAT WITHIN 10 MINUTES, THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 364 MG/DL AND 35 MG/DL ON HIS CONTOUR NEXT ONE METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747356 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 8BPEG18A

    Patients

    Seq Age Sex Outcome Treatment
    1