BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® CARE

    MDR report key: 23705404 · Received December 3, 2025

    Report

    Report Number
    1810909-2025-00162
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    August 1, 2025
    Report Date
    February 9, 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
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 # 4JSNC02A) USING BLOOD SPIKED WITH GLUCOSE AT 7.6 MMOL/L AND 3.7 MMOL/L, AS DETERMINED BY YSI INSTRUMENT IN FIVE REPLICATES EACH. ALL TESTS RECOVERED WITHIN FIT-FOR-USE LIMITS.

    Additional Manufacturer Narrative · 0

    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. THE EVENT DATE WAS PROVIDED AS AUG-2025, THEREFORE, THE EVENT DATE IN SECTION B3 HAS BEEN CAPTURED AS 01-AUG- 2025. 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 # 4JSNC02A 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 HEALTHCARE PROFESSIONAL (HCP) FROM CHINA REPORTED THAT A PATIENT'S BLOOD SAMPLE WAS TESTED USING THE CONTOUR® CARE METER, YIELDING BLOOD GLUCOSE READINGS OF 0.2 MMOL/L AND 1.7 MMOL/L. THE HCP THEN USED A NEW VIAL OF CONTOUR® CARE TEST STRIPS WITH THE SAME METER AND OBTAINED A READING OF 12 MMOL/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE TEST STRIPS HAVE BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2844471 CONTOUR® CARE BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 6284 4JSNC02A 05016003682407

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male