BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS

    MDR report key: 23062221 · Received September 16, 2025

    Report

    Report Number
    1810909-2025-00135
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 8, 2025
    Report Date
    December 4, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003764608
    PMA / PMN Number
    K210687
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORTER CONTACT DETAILS WERE NOT PROVIDED; THEREFORE, THIS INFORMATION WAS NOT CAPTURED IN SECTION E1. UNKNOWN WAS CAPTURED IN SECTION A1 AND NO INFORMATION WAS CAPTURED IN SECTION A4, AS THE PATIENT'S CREDENTIALS AND WEIGHT WERE NOT PROVIDED. THE CONTOUR® PLUS TEST STRIPS USED WITH THE CONTOUR® PLUS ONE METER IS SIMILAR TO THE CONTOUR® NEXT TEST STRIPS USED WITH THE CONTOUR® NEXT ONE METER AVAILABLE IN THE US MARKET. THE CONTOUR® PLUS TEST STRIPS WITH SKU # 7661 AND LOT # 4FQHH31A HAS THE 510K # K210687 AND UDI # (B)(4). THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE SUSPECTED CONTOUR® PLUS TEST STRIPS FROM LOT # DP4FQHC31A FOR EVALUATION. THE CONTOUR® PLUS ONE METER ASSOCIATED WITH THE EVENT WAS NOT RETURNED. THEREFORE, AN IN-HOUSE TESTING WAS PERFORMED WITH THE IN-HOUSE CONTOUR® PLUS ONE METER (SERIAL # (B)(6)) AND RETURNED TEST STRIPS USING BLOOD SPIKED WITH GLUCOSE AT 3.74 MMOL/L, AS DETERMINED BY YSI INSTRUMENT IN FIVE REPLICATES. ALL TESTS RECOVERED WITHIN FIT-FOR-USE LIMITS. BASED ON THE INFORMATION FROM THE RETURNED TEST STRIPS, THE LOT NUMBER OF THE CONTOUR® PLUS TEST STRIPS ASSOCIATED WITH THIS EVENT HAS BEEN CORRECTED FROM 4FQHH31A TO 4FQHC31A IN SECTION D4. ADDITIONALLY, THE MODEL NUMBER AND CATALOG NUMBER HAVE BEEN UPDATED. THE CONTOUR® PLUS TEST STRIPS WITH SKU # 7646B AND LOT # 4FQHC31A HAS THE 510K # K210687 AND UDI # (B)(4). THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS. THE UDI NUMBER HAS BEEN UPDATED IN SECTION D4.

    Description of Event or Problem · 0

    A NURSE FROM CHINA REPORTED THE PATIENT'S BLOOD SAMPLE WAS TESTED USING THE CONTOUR® PLUS ONE METER, AND BLOOD GLUCOSE READINGS OF 0.8 MMOL/L WERE OBTAINED TWICE USING CONTOUR® PLUS TEST STRIPS FROM LOT # 4FQHH31A. THE NURSE THEN USED A NEW BOTTLE OF TEST STRIPS AND OBTAINED A READING OF 8.7 MMOL/L. IT IS UNKNOWN WHETHER THE NEW BOTTLE OF TEST STRIPS WAS FROM THE SAME OR A DIFFERENT LOT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE NURSE 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
    2621061 CONTOUR® PLUS BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7646B 4FQHC31A 05016003764608

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male