BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® TS

    MDR report key: 22028587 · Received May 15, 2025

    Report

    Report Number
    1810909-2025-00076
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    January 23, 2019
    Report Date
    May 15, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ASCENSIA WAS MADE AWARE OF THE EVENT FROM (B)(6) 2019 ON (B)(6) 2025. SINCE THE EVENT OCCURRED IN 2019, THE CUSTOMER DISCARDED THE CONTOUR® TS METER AND TEST STRIPS ASSOCIATED WITH THE EVENT AND WAS UNABLE TO PROVIDE PRODUCT DETAILS. THEREFORE, AN IN-HOUSE TESTING COULD NOT BE PERFORMED. THE PATIENT/FAMILY (A1) WAS THE INITIAL REPORTER (E1), SO PERSONAL INFORMATION WAS NOT ENTERED. UNKNOWN WAS CAPTURED IN SECTION A1, AND NO INFORMATION WAS CAPTURED IN SECTIONS A2, A3 AND A4, AS THE PATIENT DETAILS WERE NOT PROVIDED. NO PRODUCT INFORMATION WAS PROVIDED BY THE CUSTOMER; THEREFORE, NO INFORMATION WAS CAPTURED IN SECTION D4 (MODEL #, LOT # AND EXPIRATION DATE) AND SECTION H4 (DEVICE MANUFACTURE DATE). THE CONTOUR® TS TEST STRIPS USED WITH THE CONTOUR® TS METER IS SIMILAR TO THE CONTOUR® TEST STRIPS USED WITH THE CONTOUR® METER AVAILABLE IN THE US MARKET. THEREFORE, PRODUCT CODE NBW AND MOST RECENT 510 (K) # K062058 ASSOCIATED WITH THE CONTOUR® METER MARKETED IN US WERE CAPTURED IN SECTIONS D2B AND G4 RESPECTIVELY. 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 THEY OBTAINED BLOOD GLUCOSE READINGS OF 0.9 MMOL/L AND 5.2 MMOL/L WITH THE CONTOUR® TS METER ON ONE OF THEIR PATIENTS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011113 CONTOUR® TS BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown