BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR®

    MDR report key: 21596231 · Received March 13, 2025

    Report

    Report Number
    1810909-2025-00047
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    January 18, 2025
    Report Date
    March 13, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003772702
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PICTURES PROVIDED BY THE DISTRIBUTOR WERE REVIEWED, AND IT WAS DETERMINED THAT THE CONTOUR® TEST STRIPS FROM LOT NUMBER DP3JJ3F02C HAD EXPIRATION DATES PRINTED AS 01-NOV-2024 AND 01-NOV-2026. THE EXPIRATION DATE OF 01-NOV-2024 WAS PRINTED BESIDE THE "EXPIRATION SYMBOL", WHILE THE EXPIRATION DATE OF 01-NOV-2026 WAS PRINTED BESIDE THE "EXPIRY DATE". THE UDI NUMBER ON THE PACKAGE WAS CORRECT: (B)(4). BASED ON THE TRACEABILITY RECORDS OF THE CONTOUR® TEST STRIPS WITH LOT NUMBER DP3JJ3F02C, THIS PRODUCT WAS DISTRIBUTED IN INDIA WITH THE CORRECT EXPIRATION DATE OF 31-AUG-2025 BY ASCENSIA. THE CONTOUR® TEST STRIPS FROM LOT NUMBER DP3JJ3F02C WITH INCORRECT EXPIRATION DATE WAS THEN SOLD IN IRAQ. THE CAUSE OF THE ISSUE IS ASSOCIATED WITH COUNTERFEIT PRODUCT. THERE WAS NO PATIENT INVOLVEMENT, THEREFORE, NO INFORMATION WAS CAPTURED IN SECTION A. THE CONTOUR® TEST STRIPS WITH SKU NUMBER 7727 AND LOT NUMBER DP3JJ3F02C HAS THE 510K NUMBER OF K062058 AND UDI NUMBER (B)(4). THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    AN ASCENSIA DISTRIBUTOR FROM IRAQ REPORTED THAT DURING A FIELD VISIT, THEY IDENTIFIED COUNTERFEIT CONTOUR® TEST STRIPS IN A PACKAGE CONTAINING 100 TEST STRIPS. THE LOT NUMBER DP3JJ3F02C WAS PRINTED ON THE CARTON OF THE CONTOUR® TEST STRIPS WITH INCORRECT EXPIRATION DATE. ALL OTHER INFORMATION ON THE CARTON WAS CORRECT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700891 CONTOUR® BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7727 3JJ3F02C 05016003772702

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown