BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR® NEXT

    MDR report key: 21797788 · Received April 8, 2025

    Report

    Report Number
    1810909-2025-00058
    Event Type
    Injury
    Date Received
    April 8, 2025
    Date of Event
    March 20, 2025
    Report Date
    June 19, 2025
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K241787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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® NEXT METER IS SIMILAR TO THE CONTOUR® NEXT GEN METER AVAILABLE IN THE US MARKET. THE CONTOUR® NEXT TEST STRIPS WITH SKU # 7345 AND LOT # 4BPEG05A HAS THE 510K# OF K241787 AND UDI # (B)(4). THE DEVICE WAS DISTRIBUTED OUTSIDE THE US, THEREFORE, NO GUDID INFORMATION EXISTS.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED THE SUSPECTED CONTOUR® NEXT METER WITH SERIAL # (B)(6) AND CONTOUR® NEXT TEST STRIPS FROM LOT # 4BPEG05A FOR EVALUATION. AN IN-HOUSE TESTING WAS PERFORMED WITH THE RETURNED METER AND RETURNED TEST STRIPS USING BLOOD SPIKED WITH GLUCOSE AT 134 MG/DL, AS DETERMINED BY THE YSI INSTRUMENT IN FIVE REPLICATES. ALL TESTS RECOVERED WITHIN THE FIT-FOR-USE LIMITS.

    Description of Event or Problem · 0

    AN ADVOCATE FROM AUSTRIA CALLED ON BEHALF OF HER HUSBAND, WHO WAS AT A REHABILITATION CENTER AT THE TIME OF THE EVENT, TO REPORT THAT THE BLOOD GLUCOSE READING OBTAINED ON THE CONTOUR® NEXT METER WAS HIGH. SHE PROVIDED AN EXAMPLE WHERE THE CONTOUR® NEXT METER GAVE A READING OF 140 MG/DL, WHILE AN ALTERNATE METER GAVE A READING OF 101 MG/DL. THE ADVOCATE MENTIONED THAT THE CUSTOMER EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA AND COLLAPSED ON ONE OCCASION. SHE COULD NOT SPECIFY THE TIME ELAPSED BETWEEN THE HIGH READING ON THE METER AND THE HYPOGLYCEMIC EVENT. THE CUSTOMER CONSUMED BREAD WITH JAM AND ORANGE JUICE AND RECOVERED WELL. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769876 CONTOUR® NEXT BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7346 4BPEG05A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male