BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR PLUS ELITE

    MDR report key: 17244203 · Received July 1, 2023

    Report

    Report Number
    1810909-2023-00150
    Event Type
    Malfunction
    Date Received
    July 1, 2023
    Date of Event
    June 6, 2023
    Report Date
    June 6, 2023
    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

    SINCE THE CUSTOMER DID NOT RETURN THE SUSPECTED DEVICE FOR EVALUATION, AN IN-HOUSE TESTING WAS PERFORMED WITH THE IN-HOUSE CONTOUR PLUS ELITE METER AND IN-HOUSE CONTOUR PLUS TEST STRIPS USING BLOOD SAMPLE, WHICH GAVE A SATISFACTORY PERFORMANCE. THE BLOOD GLUCOSE READINGS OBTAINED WITH THE IN-HOUSE TESTING WERE PROPERLY STORED IN THE METER'S MEMORY.

    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 # (B)(6) AND NO MANUFACTURING ANOMALIES WERE FOUND. SECTION E1 OF THE INITIAL REPORT INADVERTENTLY INDICATED THE COUNTRY OF THE INITIAL REPORTER AS USA. THE CORRECT COUNTRY OF THE INITIAL REPORTER IS MEXICO. SECTION E1 HAS BEEN UPDATED.

    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 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.

    Description of Event or Problem · 0

    THE CUSTOMER FROM MEXICO REPORTED THAT HIS BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE MEMORY OF THE CONTOUR PLUS ELITE 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
    1344896 CONTOUR PLUS ELITE BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7888

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male