BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® NEXT

    MDR report key: 17895306 · Received October 9, 2023

    Report

    Report Number
    1810909-2023-00220
    Event Type
    Malfunction
    Date Received
    October 9, 2023
    Date of Event
    September 11, 2023
    Report Date
    March 3, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003733901
    PMA / PMN Number
    P160017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION. THE TEST STRIPS ASSOCIATED WITH THE EVENT EXPIRED, THEREFORE, IN-HOUSE TEST STRIPS FROM THE SIMILAR LOT COULD NOT BE USED FOR IN-HOUSE TESTING. A DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR NEXT LINK 2.4 METER AND NO MANUFACTURING ANOMALIES WERE FOUND. IN SECTION H5 OF THE INITIAL REPORT 'NO' WAS INADVERTENTLY SELECTED FOR 'LABELED FOR SINGLE USE'. THIS SECTION HAS BEEN CORRECTED WITH 'YES'.

    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 MODEL # (D4) WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY: SECTIONS D1 (BRAND NAME), D4 (MODEL #, CATALOG # AND UDI #) AND G4 (510K #) HAVE BEEN UPDATED. CONTOUR® NEXT TEST STRIPS WITH SKU # 7339, 510K # P160017 AND UDI # (B)(4) WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    THE CUSTOMER FROM UNITED KINGDOM REPORTED THAT WITHIN 10 MINUTES SHE OBTAINED BLOOD GLUCOSE READINGS OF 1.8 MMOL/L, 1.8 MMOL/L, 4.2 MMOL/L, AND 5.8 MMOL/L WITH THE CONTOUR NEXT LINK 2.4 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
    1249243 CONTOUR® NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7339 1JPEF03B 05016003733901

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female