BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS

    MDR report key: 23467274 · Received November 4, 2025

    Report

    Report Number
    1810909-2025-00156
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 4, 2025
    Report Date
    March 23, 2026
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K191286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE THE FOLLOW-UP ATTEMPTS, THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION. THEREFORE, AN IN-HOUSE TESTING WAS PERFORMED WITH THE IN-HOUSE CONTOUR® PLUS METER (SERIAL # (B)(6)) AND IN-HOUSE CONTOUR® PLUS TEST STRIPS (LOT # 4LQHG01B) USING BLOOD SPIKED WITH GLUCOSE AT 137 MG/DL AND 66 MG/DL, AS DETERMINED BY YSI INSTRUMENT IN FIVE REPLICATES EACH. ALL TESTS RECOVERED WITHIN FIT-FOR-USE LIMITS. ADDITIONALLY, THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR® PLUS METER (SERIAL # (B)(6)) AND NO MANUFACTURING ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 0

    THE PATIENT/FAMILY (A1) WAS THE INITIAL REPORTER (E1), SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED IN SECTION A4 AS THE CUSTOMER'S WEIGHT WAS NOT PROVIDED. SKU#: 7706 OF THE CONTOUR® PLUS TEST STRIPS IS ONLY AVAILABLE IN MEXICO; THEREFORE, THE UDI# IS NOT APPLICABLE. THE CONTOUR® PLUS TEST STRIPS USED WITH THE CONTOUR® PLUS METER IS SIMILAR TO THE CONTOUR® NEXT TEST STRIPS USED WITH THE CONTOUR® NEXT METER AVAILABLE IN THE US MARKET. THEREFORE, PRODUCT CODE NBW AND MOST RECENT 510 (K)#: K191286 ASSOCIATED WITH THE CONTOUR® NEXT METER MARKETED IN US WERE CAPTURED IN SECTIONS D2B AND G4 RESPECTIVELY. THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE SUSPECTED CONTOUR® PLUS METER WITH SERIAL # (B)(6) FOR EVALUATION. NO TEST STRIPS WERE RETURNED. THEREFORE, AN IN-HOUSE TESTING WAS PERFORMED WITH THE RETURNED METER AND IN-HOUSE CONTOUR® PLUS TEST STRIPS (LOT # 4LQHG01B) USING BLOOD SPIKED WITH GLUCOSE AT 136 MG/DL AND 67 MG/DL, AS DETERMINED BY YSI INSTRUMENT IN FIVE REPLICATES EACH. ALL TESTS RECOVERED WITHIN FIT-FOR-USE LIMITS.

    Description of Event or Problem · 0

    THE CUSTOMER FROM MEXICO REPORTED THAT HE OBTAINED BLOOD GLUCOSE READINGS OF 26 MG/DL AT 5:00 P.M., 128 MG/DL AT 5:03 P.M. AND 45 MG/DL AT 5:09 P.M. WITH THE CONTOUR® PLUS METER. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584746 CONTOUR® PLUS BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7706 4LQHG01B

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male