BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® CARE

    MDR report key: 22205699 · Received June 13, 2025

    Report

    Report Number
    1810909-2025-00093
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 19, 2025
    Report Date
    July 16, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003680700
    PMA / PMN Number
    K231679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE SUSPECTED CONTOUR® CARE METER WITH SERIAL # (B)(6) FOR EVALUATION. NO TEST STRIPS OR CONTROL SOLUTION WERE RETURNED. THE RETURNED METER WAS TESTED WITH THE IN-HOUSE CONTOUR® CARE TEST STRIPS FROM LOT # 3HSNC01A AND IN-HOUSE CONTOUR® NEXT CONTROL SOLUTION FROM LOT # 4BV2D54 AND THE RESULT OBTAINED WAS WITHIN THE ACCEPTABLE CONTROL RANGE. ADDITIONAL TESTING WITH BLOOD SAMPLE WILL BE PERFORMED IN THE QUALITY LABORATORY. THE PATIENT/FAMILY (A1) WAS THE INITIAL REPORTER (E1), SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED IN SECTIONS A2 AND A4 AS THE CUSTOMER'S AGE AND WEIGHT WERE NOT PROVIDED. CONTOUR® CARE METER IS SIMILAR TO THE CONTOUR® PLUS BLUE METER AVAILABLE IN THE US MARKET. THE CONTOUR® CARE TEST STRIPS WITH SKU # 6807 AND LOT # 3GSNC04A HAS THE 510K # OF K231679 AND UDI # (B)(4). THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Additional Manufacturer Narrative · 0

    AN IN-HOUSE TESTING WAS PERFORMED WITH THE RETURNED CONTOUR® CARE METER SERIAL # (B)(6) AND IN-HOUSE CONTOUR® CARE TEST STRIPS LOT # 3GSNC04A USING BLOOD SPIKED WITH GLUCOSE AT 404 MG/DL AND 135 MG/DL, AS DETERMINED BY THE YSI INSTRUMENT IN FIVE REPLICATES EACH. ALL TESTS RECOVERED WITHIN THE FIT-FOR-USE LIMITS. ADDITIONALLY, THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE CONTOUR® CARE METER SERIAL # (B)(6) AND CONTOUR® CARE TEST STRIPS LOT # 3GSNC04A AND NO MANUFACTURING ANOMALIES WERE FOUND.

    Description of Event or Problem · 0

    THE CUSTOMER FROM GREECE REPORTED THAT SHE OBTAINED BLOOD GLUCOSE READINGS OF 178 MG/DL, 83 MG/DL, 380 MG/DL AND 167 MG/DL WITHIN 3 MINUTES WITH THE CONTOUR® CARE 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
    343231 CONTOUR® CARE BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 6807 3GSNC04A 05016003680700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female