BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® CARE

    MDR report key: 21548520 · Received March 7, 2025

    Report

    Report Number
    1810909-2025-00040
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    February 7, 2025
    Report Date
    April 2, 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. THEREFORE, THE RETURNED METER, THE IN-HOUSE CONTOUR® CARE TEST STRIPS FROM LOT # 3HSNC01A AND THE IN-HOUSE CONTOUR® NEXT CONTROL SOLUTION FROM LOT # 4BV2D54 WERE USED FOR IN-HOUSE TESTING AND A READING OF 121 MG/DL WAS OBTAINED, WHICH WAS WITHIN THE NORMAL RANGE. FURTHER TESTING WILL BE PERFORMED BY QUALITY LABORATORY USING BLOOD SPIKED WITH GLUCOSE. 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 # 4BSNC01C 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

    THE RETUNED CONTOUR® CARE METER WITH SERIAL # (B)(6) AND THE IN-HOUSE CONTOUR® CARE TEST STRIPS FROM LOT # 4BSNC01C WERE USED FOR IN-HOUSE TESTING, USING BLOOD SPIKED WITH GLUCOSE AT 135 MG/DL AND 67 MG/DL, AS DETERMINED BY THE YSI INSTRUMENT IN FIVE REPLICATES EACH. ALL TESTS RECOVERED WITHIN THE FIT-FOR-USE LIMITS.

    Description of Event or Problem · 0

    AN ADVOCATE FROM GREECE REPORTED ON BEHALF OF THEIR WIFE THAT THE CUSTOMER USED THE CONTOUR® CARE METER FOR BLOOD GLUCOSE TESTING. THE READINGS WERE 16 MG/DL AT 6:23 P.M. AND 42 MG/DL AT 6:31 P.M. USING LOT # 4BSNC01C OF THE CONTOUR® CARE TEST STRIPS. ANOTHER TEST WAS PERFORMED AT 6:29 P.M., PRODUCING A READING OF 182 MG/DL WITH A DIFFERENT VIAL OF CONTOUR® CARE TEST STRIPS, THOUGH THE LOT NUMBER FOR THIS VIAL WAS NOT PROVIDED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE 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
    1423875 CONTOUR® CARE BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 6807 4BSNC01C 05016003680700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female