BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS

    MDR report key: 18200053 · Received November 23, 2023

    Report

    Report Number
    1810909-2023-00253
    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.

    Additional Manufacturer Narrative · 0

    THE CONTOUR PLUS TEST STRIPS WITH LOT # DP1DQHH32B PRINTED ON IT WAS RETURNED FOR EVALUATION. UPON INVESTIGATION, IT WAS DETERMINED THAT THE RETURNED PRODUCT HAD EXPIRATION DATE AS JAN-2025 AND CONTROL RANGES AS 110-143 MG/DL OR 6.1-8.0 MMOL/L (NORMAL), 37-48 MG/DL OR 2.0-2.7 MMOL/L (LOW) AND 332-418 MG/DL OR 17.8-23.2 MMOL/L (HIGH) PRINTED ON THE CARTON AND VIAL OF THE TEST STRIPS. HOWEVER, WHEN THE BOTTOM OF THE VIAL WAS CHECKED, THE LOT # WAS PRINTED AS 2LQHH06. THE CORRECT CONTROL RANGES FOR LOT # DP1DQHH32B IS 110-143 MG/DL OR 6.1-7.9 MMOL/L (NORMAL), 37-48 MG/DL OR 2.0-2.7 MMOL/L (LOW) AND 322-418 MG/DL OR 17.8-23.2 MMOL/L (HIGH). WHILE THE CORRECT CONTROL RANGES FOR LOT # 2LQHH06 IS 112-146 MG/DL OR 6.2-8.1 MMOL/L (NORMAL), 37-49 MG/DL OR 2.1-2.7 MMOL/L (LOW) AND 334-434 MG/DL OR 18.5-24.1 MMOL/L (HIGH). THE CORRECT EXPIRATION DATE FOR LOT # 2LQHH06 IS NOV-2024 AND THAT OF LOT # DP1DQHH32B IS APR-2023. THE CARTON APPEARED TO BE COUNTERFEIT AS THE FONT WAS INCORRECT FOR LOT # AND EXPIRATION DATE AND THE EXPIRATION DATE AND CONTROL RANGES WERE INCORRECT. THE CARTON HAD A GLOSSY FINISH, NOT THE MATTE FINISH THAT ASCENSIA USES FOR PACKAGING. THE QUANTITY OF THE TEST STRIPS IN THE EACH VIAL WAS IS 50S WHICH IS NOT THE QUANTITY AVAILABLE IN VIETNAM MARKET, AS ONLY 25S IS AVAILABLE. UPON OPENING OF THE VIAL, IT WAS DETERMINED THAT THE GLUE USED TO SEAL THE CARTON WAS NOT THE SAME AS THAT USED BY ASCENSIA AND THE VIAL LID WAS DIFFICULT TO OPEN AND TORE EASILY. LOT # 2LQHH06 PRINTED ON THE BOTTOM OF THE VIAL OF TEST STRIPS IS THE PRODUCT TO BE MARKETED IN SOUTH KOREAN MARKET. HOWEVER, THE LOT # DP1DQHH32B PRINTED ON THE VIAL AND CARTON OF TEST STRIPS IS A VIETNAMESE LOT. NO INFORMATION WAS CAPTURED IN SECTION A (A1 - PATIENT INITIALS, A2 - AGE, A3 - GENDER, A4-WEIGHT), AS NO PATIENT WAS INVOLVED. THE MODEL # (D4) WAS NO PROVIDED. THIS EVENT IS RELATED TO MDR 1810909-2023-00254.

    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
    223511 CONTOUR® PLUS BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7647 2LQHH06 05016003764707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown