BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 20594325 · Received November 2, 2024

    Report

    Report Number
    1810909-2024-00167
    Event Type
    Malfunction
    Date Received
    November 2, 2024
    Date of Event
    September 26, 2024
    Report Date
    January 10, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    JJX
    UDI-DI
    10301937314015
    PMA / PMN Number
    K151742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AS PER THE CONTOUR NEXT CONTROL SOLUTION USER MANUAL, SQUEEZE A SMALL DROP OF SOLUTION ONTO A CLEAN, NON-ABSORBENT SURFACE. THE CUSTOMER DID NOT FOLLOW THIS INSTRUCTION. THE PATIENT/FAMILY (A1) WAS THE INITIAL REPORTER (E1), SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED IN SECTION AND A4 AS THE CUSTOMER'S WEIGHT WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE SUSPECTED DEVICE FOR EVALUATION. THEREFORE, AN IN-HOUSE CONTOUR® NEXT ONE METER WITH SERIAL # (B)(6), IN-HOUSE CONTOUR® NEXT TEST STRIPS FROM LOT # 3FHEC43A AND IN-HOUSE CONTOUR® NEXT CONTROL SOLUTION FROM LOT # 3BV2G17 WERE USED FOR IN-HOUSE TESTING IN FIVE REPLICATES. ALL CONTROL TESTS WERE REPRODUCIBLE AND FELL WITHIN THE CONTROL RANGES OF 113-141 MG/DL. THE CONTROL RESULTS OBTAINED WITH THE IN-HOUSE TESTING WERE PROPERLY MARKED AS CONTROL RESULTS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT HE RAN CONTROL TESTS WITH THE CONTOUR NEXT ONE METER AND OBTAINED READINGS OF 151 MG/DL AT 9:23 P.M., 219 MG/DL AT 9:25 P.M. AND 227 MG/DL AT 9:32 P.M. THE METER DID NOT AUTOMATICALLY MARK IT AS CONTROL TESTS, AND SO THE READINGS WILL BE DISPLAYED AS BLOOD RESULTS WHEN ACCESSING THE METER'S MEMORY. 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
    2176656 CONTOUR NEXT QUALITY CONTROL MATERIAL JJX ASCENSIA DIABETES CARE US INC. 7314 3BV2G17 10301937314015

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male