BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® TS

    MDR report key: 22862688 · Received August 21, 2025

    Report

    Report Number
    1810909-2025-00122
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    July 27, 2025
    Report Date
    April 27, 2026
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE FOLLOW-UP ATTEMPT, THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION. THEREFORE, A DEVICE HISTORY RECORD FOR THE SUSPECTED CONTOUR® TS TEST STRIPS WITH LOT # 4KM3F03B WAS REVIEWED AND NO MANUFACTURING ANOMALIES WERE FOUND. BASED ON THE DEVICE HISTORY RECORD REVIEW, THE LOT # FOR THE CONTOUR® TS TEST STRIPS HAS BEEN UPDATED FROM 4KM3FD3B TO 4KM3F03B IN SECTION D4.

    Additional Manufacturer Narrative · 0

    THE PATIENT/FAMILY (A1) WAS THE INITIAL REPORTER (E1), SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED IN SECTIONS A2, A3 AND A4 AS THE CUSTOMER'S AGE, SEX AND WEIGHT WERE NOT PROVIDED. THE CUSTOMER DID NOT PROVIDE THE SKU # FOR THE CONTOUR® TS TEST STRIPS, THEREFORE THE MODEL # AND CATALOG # WERE NOT CAPTURED IN SECTION D4. THE CONTOUR® TS TEST STRIP IS SIMILAR TO THE CONTOUR® TEST STRIP AVAILABLE IN THE US MARKET. THEREFORE, PRODUCT CODE NBW AND MOST RECENT 510 (K) # K062058 ASSOCIATED WITH THE CONTOUR® TEST STRIP MARKETED IN US WERE CAPTURED IN SECTIONS D2B AND G4 RESPECTIVELY. THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, UDI NUMBER IS NOT APPLICABLE AND NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    THE CUSTOMER FROM MEXICO REPORTED THAT THEY OPENED A BOX OF THE CONTOUR® TS TEST STRIPS AND THE BOTTLE WAS ALREADY OPEN WITH THE STRIPS BEING OUTSIDE THE BOTTLE. 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
    153430 CONTOUR® TS BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 4KM3F03B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown