BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 12181040 · Received July 16, 2021

    Report

    Report Number
    1810909-2021-00292
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    July 2, 2021
    Report Date
    July 2, 2021
    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 (CONNECTED) METER AND CONTOUR NEXT TEST STRIPS FROM LOT#: 0HPEG01A FOR EVALUATION. THE RETURNED METER WAS TESTED WITH THE RETURNED 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, GENDER 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 GERMANY REPORTED THAT WITHIN 5 MINUTES THEY OBTAINED BLOOD GLUCOSE READINGS OF 350 MG/DL AND 40 MG/DL WITH THEIR CONTOUR NEXT (CONNECTED) METER. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081050 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 0HPEG01A

    Patients

    Seq Age Sex Outcome Treatment
    1