BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS

    MDR report key: 23027415 · Received September 11, 2025

    Report

    Report Number
    1810909-2025-00134
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 15, 2025
    Report Date
    December 19, 2025
    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

    THE CUSTOMER RETURNED THE SUSPECTED CONTOUR® PLUS METER (SERIAL # (B)(6)) FOR EVALUATION. NO TEST STRIPS WERE RETURNED. AN IN-HOUSE TESTING WAS PERFORMED WITH THE RETURNED METER AND IN-HOUSE CONTOUR® PLUS TEST STRIPS (LOT # 4KQHH08D) USING BLOOD SPIKED WITH GLUCOSE AT 131 MG/DL, AS DETERMINED BY YSI INSTRUMENT IN FIVE REPLICATES. ALL TESTS RECOVERED WITHIN FIT-FOR-USE LIMITS. THE BLOOD GLUCOSE RESULTS OBTAINED WITH THE IN-HOUSE TESTING WERE PROPERLY STORED IN THE METER'S MEMORY.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR® PLUS METER (SERIAL # (B)(6)), AND NO MANUFACTURING ANOMALIES WERE FOUND. 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. THE CONTOUR® PLUS METER DOES NOT HAVE AN EXPIRATION DATE. THEREFORE, NO INFORMATION WAS CAPTURED IN SECTION D4 (EXPIRATION DATE). THE WARRANTY PERIOD OF THE METER IS 5 YEARS FROM THE DATE OF THE ORIGINAL PURCHASE. SKU # 7703 OF THE CONTOUR® PLUS METER IS ONLY AVAILABLE IN MEXICO; THEREFORE, THE UDI # IS NOT APPLICABLE. CONTOUR® PLUS METER IS SIMILAR TO THE CONTOUR® NEXT METER AVAILABLE IN 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.

    Description of Event or Problem · 0

    THE CUSTOMER FROM MEXICO CONTACTED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® PLUS METER. DURING TROUBLESHOOTING, IT WAS FOUND THAT THE BLOOD GLUCOSE READINGS WERE NOT BEING STORED IN THE METER'S MEMORY. 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
    2330337 CONTOUR® PLUS BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7703 DP03V036P

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female