BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 8953600 · Received September 2, 2019

    Report

    Report Number
    1810909-2019-00388
    Event Type
    Malfunction
    Date Received
    September 2, 2019
    Date of Event
    August 10, 2019
    Report Date
    August 10, 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 CONTOUR NEXT TEST STRIPS LOT # 8CPEC52C FOR EVALUATION. BASED ON THIS INFORMATION, LOT # AND EXPIRATION DATE IN SECTION D4 AND DEVICE MANUFACTURE DATE IN SECTION H4 HAVE BEEN UPDATED. IN ADDITION TO THE CONTOUR NEXT TEST STRIPS LOT # 8CPEC52C, THE CUSTOMER ALSO RETURNED THE SUSPECTED CONTOUR NEXT ONE METER. AN IN-HOUSE TESTING WAS PERFORMED USING THE RETURNED METER AND RETURNED TEST STRIPS. ALSO, TESTING WAS ALSO PERFORMED USING THE RETURNED METER AND IN-HOUSE TEST STRIPS FROM LOT # 8CPEC52C. 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. SINCE NO PRODUCT DETAILS WERE PROVIDED, MODEL #, LOT # AND EXPIRATION DATE WERE NOT CAPTURED AND DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS EVENT IS RELATED TO MDRS 1810909-2019-00383, 1810909-2019-00384, 1810909-2019-00385, 1810909-2019-00386, AND 1810909-2019-00387.

    Description of Event or Problem · 1

    AN ADVOCATE FROM (B)(6) REPORTED THAT THE CUSTOMER OBTAINED BLOOD GLUCOSE READINGS OF 409 MG/DL AND 193 MG/DL ON THE CONTOUR NEXT ONE METER. THE CUSTOMER HAD NO SYMPTOMS OF HYPERGLYCEMIA. 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. THE CUSTOMER DID NOT PROVIDE THE PRODUCT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747307 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 8CPEC52C

    Patients

    Seq Age Sex Outcome Treatment
    1