BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR PLUS ELITE

    MDR report key: 20026086 · Received August 22, 2024

    Report

    Report Number
    1810909-2024-00134
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 24, 2024
    Report Date
    July 24, 2024
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K193407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT/FAMILY (A1) WAS THE INITIAL REPORTER (E1), SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED IN SECTION A4 AS THE CUSTOMER'S WEIGHT WAS NOT PROVIDED. THE DEVICE IDENTIFIER # IN SECTION D4 WAS LEFT BLANK AS IT IS NOT APPLICABLE. THE CONTOUR PLUS ELITE METER IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE CONTOUR NEXT GEN METER WITH THE PRODUCT CODE NBW AND 510 (K) # K193407, WHICH IS MARKETED IN THE UNITED STATES.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION. THEREFORE, A DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR PLUS ELITE METER WITH SERIAL # 1704384, AND NO MANUFACTURING ANOMALIES WERE FOUND.

    Description of Event or Problem · 0

    THE CUSTOMER FROM MEXICO CALLED TO SEEK ASSISTANCE WITH THEIR CONTOUR PLUS ELITE METER. DURING TROUBLESHOOTING, IT WAS FOUND THAT ONE OF HER BLOOD GLUCOSE READINGS WAS NOT STORED IN THE METER'S MEMORY. 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
    2358344 CONTOUR PLUS ELITE BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7888

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female