BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR® PLUS ELITE

    MDR report key: 22028576 · Received May 15, 2025

    Report

    Report Number
    1810909-2025-00074
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    April 21, 2025
    Report Date
    July 22, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K223293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE SUSPECTED CONTOUR® PLUS ELITE METER SERIAL # (B)(6), AND CONTOUR® PLUS TEST STRIPS LOT # DP4FQHH05A, FOR EVALUATION. THE LOT # OF THE RETURNED TEST STRIPS WAS DIFFERENT FROM THE ONE ASSOCIATED WITH THE EVENT, WHICH WAS 4GQHH01A. THEREFORE, AN IN-HOUSE TESTING WAS PERFORMED WITH THE RETURNED METER AND RETURNED TEST STRIPS USING BLOOD SPIKED WITH GLUCOSE AT 135 MG/DL AND 68 MG/DL, AS DETERMINED BY THE YSI INSTRUMENT IN FIVE REPLICATES EACH. ADDITIONALLY, THE RETURNED METER WAS TESTED WITH IN-HOUSE CONTOUR® PLUS TEST STRIPS FROM LOT # 4GQHH01A USING BLOOD SPIKED WITH GLUCOSE AT 135 MG/DL AND 68 MG/DL, AS DETERMINED BY THE YSI INSTRUMENT IN FIVE REPLICATES EACH. ALL TESTS RECOVERED WITHIN THE FIT-FOR-USE LIMITS AND WERE PROPERLY STORED IN THE METER'S MEMORY.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD WAS REVIEWED FOR THE SUSPECTED CONTOUR® PLUS ELITE METER WITH SERIAL # (B)(6) AND NO MANUFACTURING ANOMALIES WERE FOUND. THE PATIENT/FAMILY (A1) WAS THE INITIAL REPORTER (E1), SO PERSONAL INFORMATION WAS NOT ENTERED. NO INFORMATION WAS CAPTURED IN SECTION A4 AS THE CUSTOMER'S WEIGHT WAS NOT PROVIDED. THE CONTOUR® PLUS ELITE METER DOES NOT HAVE AN EXPIRATION DATE. THEREFORE, NO INFORMATION WAS CAPTURED IN SECTION D4 (EXPIRATION DATE). THE WARRANTY PERIOD OF THE METER IS 5 YEARS FROM THE DATE OF THE ORIGINAL PURCHASE. SKU # 7888 OF THE CONTOUR® PLUS ELITE METER IS ONLY AVAILABLE IN MEXICO; THEREFORE, THE UDI # IS NOT APPLICABLE. CONTOUR® PLUS ELITE METER IS SIMILAR TO THE CONTOUR® NEXT GEN METER AVAILABLE IN US MARKET. THEREFORE, PRODUCT CODE NBW AND MOST RECENT 510 (K) # K223293 ASSOCIATED WITH THE CONTOUR® NEXT GEN METER MARKETED IN US WERE CAPTURED IN SECTIONS D2B AND G4 RESPECTIVELY. THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Description of Event or Problem · 0

    A CUSTOMER FROM MEXICO CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® PLUS ELITE METER. DURING THE TROUBLESHOOTING, IT WAS FOUND THAT AFTER REPLACING THE METER'S BATTERY, ONE OF THE CUSTOMER'S BLOOD GLUCOSE READINGS WAS NOT STORED IN THE METER'S MEMORY. 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
    1833038 CONTOUR® PLUS ELITE BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7888 DP01U283P

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female