BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS

    MDR report key: 18200052 · Received November 23, 2023

    Report

    Report Number
    1810909-2023-00254
    Event Type
    Malfunction
    Date Received
    November 23, 2023
    Date of Event
    October 26, 2023
    Report Date
    March 3, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    UDI-DI
    05016003764707
    PMA / PMN Number
    K223293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY: SECTIONS D1 (BRAND NAME), D4 (MODEL #, CATALOG # AND UDI #) AND G4 (510K #) HAVE BEEN UPDATED. CONTOUR® PLUS TEST STRIPS WITH SKU # 7647, 510K # K223293 AND UDI # (B)(4) WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    A COMMERCIAL TEAM FIELD VISIT TO A LOCAL VIETNAMESE PHARMACY IDENTIFIED COUNTERFEIT CONTOUR PLUS TEST STRIPS. LOT # DP1DQHH32B WAS PRINTED ON THE VIAL AND CARTON OF THE CONTOUR PLUS TEST STRIPS WITH INCORRECT CONTROL RANGES AND EXPIRATION DATE. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223510 CONTOUR® PLUS BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7647 3AQHH06 05016003764707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown