BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT (CONNECTED)

    MDR report key: 11966725 · Received June 9, 2021

    Report

    Report Number
    1810909-2021-00248
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 18, 2021
    Report Date
    May 18, 2021
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K160682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT INDICATED THAT THE DEVICE INVOLVED IN THE EVENT OCCURRENCE WAS THE CONTOUR NEXT METER. BASED ON THE INFORMATION RECEIVED UPON THE METER RETURN, IT WAS DETERMINED THAT THE METER INVOLVED DURING THE EVENT OCCURRENCE WAS CONTOUR NEXT (CONNECTED). SECTIONS B5, D4 (BRAND NAME), G1 CONTINUED (MANUFACTURING SITE), G5 (510K#), AND H4 (DEVICE MANUFACTURE DATE) HAVE BEEN UPDATED. 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. THE CUSTOMER RETURNED THE SUSPECTED CONTOUR NEXT (CONNECTED) METER FOR EVALUATION. THE RETURNED METER WAS TESTED WITH THE IN-HOUSE CONTOUR NEXT TEST STRIPS USING A BLOOD SAMPLE, WHICH GAVE A SATISFACTORY PERFORMANCE. THE BLOOD READINGS OBTAINED DURING IN-HOUSE TESTING WERE PROPERLY STORED IN THE METER'S MEMORY.

    Description of Event or Problem · 0

    THE CUSTOMER FROM GREECE REPORTED THAT ONE OF THEIR BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR NEXT (CONNECTED) METER.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER FROM (B)(6) REPORTED THAT ONE OF THEIR BLOOD GLUCOSE READINGS WAS NOT STORED IN THE MEMORY OF THE CONTOUR NEXT METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862463 CONTOUR NEXT (CONNECTED) BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1