BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT (CONNECTED)

    MDR report key: 11744279 · Received April 29, 2021

    Report

    Report Number
    1810909-2021-00197
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 8, 2021
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K160682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE SUSPECTED CONTOUR NEXT (CONNECTED) METER FOR EVALUATION. NO TEST STRIPS WERE RETURNED. THEREFORE, THE RETURNED METER WAS TESTED WITH THE IN-HOUSE CONTOUR NEXT TEST STRIPS USING A BLOOD SAMPLE, WHICH GAVE A SATISFACTORY PERFORMANCE.

    Additional Manufacturer Narrative · 1

    THE PATIENT/FAMILY WAS THE INITIAL REPORTER, SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED AS THE CUSTOMER'S AGE AND WEIGHT WERE NOT PROVIDED. THE MODEL # WAS NOT PROVIDED. THE CONTOUR NEXT (CONNECTED) METER IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE CONTOUR NEXT ONE METER WITH THE PRODUCT CODE NBW AND 510 (K) # K160682, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    THE CUSTOMER FROM (B)(6) REPORTED THAT WITHIN 10 MINUTES, HE OBTAINED BLOOD GLUCOSE READINGS OF 221 MG/DL AND 21 MG/DL ON THE CONTOUR NEXT (CONNECTED) METER. THE CUSTOMER DID NOT EXPERIENCE SYMPTOMS OF HYPOGLYCEMIA. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644477 CONTOUR NEXT (CONNECTED) BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1