BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® CARE

    MDR report key: 24967443 · Received April 23, 2026

    Report

    Report Number
    1810909-2026-00020
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    December 11, 2025
    Report Date
    April 23, 2026
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003682407
    PMA / PMN Number
    K241787
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN THE SUSPECTED DEVICE FOR EVALUATION. THEREFORE, AN IN-HOUSE TESTING WAS PERFORMED WITH THE IN-HOUSE CONTOUR® CARE METER (SERIAL # (B)(6)) AND IN-HOUSE CONTOUR® CARE TEST STRIPS (LOT # 4LSNC06A) USING BLOOD SPIKED WITH GLUCOSE AT 7.49 MMOL/L, AS DETERMINED BY YSI INSTRUMENT IN FIVE REPLICATES. ALL TESTS RECOVERED WITHIN FIT-FOR USE LIMITS. THE INITIAL REPORTER'S CONTACT DETAILS WERE NOT PROVIDED; THEREFORE, THIS INFORMATION WAS NOT CAPTURED IN SECTION E1. UNKNOWN WAS RECORDED IN SECTION A1, AND NO INFORMATION WAS CAPTURED IN SECTION A4, AS THE PATIENT'S CREDENTIALS AND WEIGHT WERE NOT PROVIDED. CONTOUR® CARE METER IS SIMILAR TO THE CONTOUR® PLUS BLUE METER AVAILABLE IN THE US MARKET. THE CONTOUR® CARE TEST STRIPS WITH SKU # 6824 AND LOT # 4LSNC06A HAS THE 510K # OF K241787 AND UDI # (B)(4). THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL FROM CHINA REPORTED THAT WHILE PERFORMING BLOOD GLUCOSE TESTING WITH THE CONTOUR® CARE METER ON ONE OF THEIR PATIENTS, THEY OBTAINED AN E20 ERROR MESSAGE, INDICATIVE OF TESTING ERROR AND THEN A READING OF 1.6 MMOL/L WITH THE METER. ANOTHER TEST WAS PERFORMED IN THE LABORATORY, AND A READING OF 9.5 MMOL/L WAS OBTAINED. THE PATIENT WAS GIVEN AN INTRAVENOUS INJECTION OF 40 ML OF 50% GLUCOSE BASED ON THE METER RESULT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION, AS THE TEST STRIPS FROM THE VIAL WERE ALREADY USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95868 CONTOUR® CARE BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 6824 4LSNC06A 05016003682407

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male