BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR PLUS

    MDR report key: 20834056 · Received December 3, 2024

    Report

    Report Number
    1810909-2024-00180
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    October 7, 2024
    Report Date
    January 30, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K121190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE SUSPECTED CONTOUR® PLUS METER WITH S/N: A183000 AND CONTOUR® PLUS TEST STRIPS FROM LOT # 4BQHH10A FOR EVALUATION. THE RETURNED METER WAS TESTED WITH THE RETURNED TEST STRIPS AND IN-HOUSE CONTOUR® PLUS TEST STRIPS FROM LOT # 4BQHH08A AND 3 LEVELS OF CONTOUR® PLUS CONTROL SOLUTIONS FROM LOT #S 3HV2I14, 3BV1R29 AND 3BV3R29. ALL RESULTS WERE WITHIN SPECIFICATION. SINCE THE STRIPS INFORMATION HAS BEEN PROVIDED, SECTIONS D2 (COMMON DEVICE NAME), D4 (MODEL #, CATALOG #, LOT # AND EXPIRATION DATE), G1 (CONTACT OFFICE - MANUFACTURING SITE), H5 (LABELED FOR SINGLE USE) AND H8 (USAGE OF DEVICE) HAVE BEEN UPDATED. MODEL # 7632 OF THE CONTOUR® PLUS TEST STRIPS IS ONLY AVAILABLE IN TURKEY; THEREFORE, THE UDI # IS NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    THE PATIENT/FAMILY (A1) WAS THE INITIAL REPORTER (E1), SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED IN SECTIONS A2 AND A4 AS THE CUSTOMER'S AGE AND WEIGHT WERE NOT PROVIDED. THE DEVICE MODEL # (D4) WAS NOT PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER FROM TURKEY REPORTED THAT WITHIN 10 MINUTES, HE OBTAINED BLOOD GLUCOSE READINGS OF 108 MG/DL WITH THE CONTOUR PLUS METER AND 68 MG/DL WITH THE LABORATORY TESTING. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. SINCE THE STRIP INFORMATION WAS NOT PROVIDED, THIS REPORT WILL BE SUBMITTED UNDER THE METER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377920 CONTOUR PLUS BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7632 4BQHH10A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male