BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT (CONNECTED)

    MDR report key: 9889455 · Received March 27, 2020

    Report

    Report Number
    1810909-2020-00158
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Date of Event
    March 2, 2020
    Report Date
    March 2, 2020
    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 TWO CONTOUR NEXT (CONNECTED) METERS (SERIAL #S (B)(6)) FOR EVALUATION. THE CUSTOMER ONLY USED CONTOUR NEXT (CONNECTED) METER WITH SERIAL # (B)(6)DURING THE EVENT. NO TEST STRIPS WERE RETURNED. THEREFORE, IN-HOUSE TESTING WAS PERFORMED USING THE RETURNED METERS WITH IN-HOUSE CONTOUR NEXT TEST STRIPS, WHICH GAVE A SATISFACTORY PERFORMANCE.

    Additional Manufacturer Narrative · 1

    DUE TO THE COVID-19 PANDEMIC, THE INVESTIGATION FOR THIS EVENT WILL BE DELAYED. WE WILL HOWEVER, SEND THE FOLLOW-UP REPORT AS SOON AS OUR LABORATORY SERVICES ARE ABLE TO RETURN TO NORMAL. THE PATIENT/FAMILY WAS THE INITIAL REPORTER, SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED AS THE CUSTOMER'S WEIGHT WAS 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 THERE WAS A DIFFERENCE OF 150 TO 200 MG/DL BETWEEN THE BLOOD GLUCOSE READINGS OBTAINED ON THE CONTOUR NEXT (CONNECTED) METER TO THAT OF THE HOSPITAL'S METER. THE CONTOUR NEXT (CONNECTED) METER USED BY THE CUSTOMER HAD THE UNITS OF MEASUREMENT SET TO MMOL/L. NO SPECIFIC READINGS WERE PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER AND TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353093 CONTOUR NEXT (CONNECTED) BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR