BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 23735985 · Received December 8, 2025

    Report

    Report Number
    3009862700-2025-02014
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    November 5, 2025
    Report Date
    January 15, 2026
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D2B.CORRECTED FROM SBA TO QHJ.

    Additional Manufacturer Narrative · 0

    THE AUTHORIZED REPRESENTATIVE (AR) REPORTED TAKING THE USER TO THE ER ON 05-NOV-2025 AT 7:30 PM EST. ACCORDING TO THE AR, THE USER WAS EXPERIENCING NAUSEA AND VOMITING, PROMPTING THE ER VISIT. THE USER WAS DIAGNOSED WITH STAGE 3 KIDNEY DISEASE. AT THE TIME OF THE LAST CALL, THE USER STATED THEY WERE FEELING FINE.THE USER CONFIRMED THE EVENT WAS NOT RELATED TO THE SENSOR INSERTION OR REMOVAL AND WAS NOT RELATED TO DIABETES. THE USER'S HCP IS AWARE OF THE EVENT.NO CURRENT DMS DATA IS AVAILABLE, AS THE USER'S SYSTEM REACHED END OF LIFE ON 03-NOV-2024. PER DMS, THE USER HAS NOT USED THE SYSTEM SINCE WEDNESDAY, 13-NOV-2024 AT 8:53 AM.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE AUTHORIZED REPRESENTATIVE (AR) REPORTED TAKING THE USER TO THE ER ON (B)(6) 2025 AT 7:30 PM EST. ACCORDING TO THE AR, THE USER WAS EXPERIENCING NAUSEA AND VOMITING, PROMPTING THE ER VISIT. THE USER WAS DIAGNOSED WITH STAGE 3 KIDNEY DISEASE. AT THE TIME OF THE LAST CALL, THE USER STATED THEY WERE FEELING FINE. THE USER CONFIRMED THE EVENT WAS NOT RELATED TO THE SENSOR INSERTION OR REMOVAL AND WAS NOT RELATED TO DIABETES. THE USER'S HCP IS AWARE OF THE EVENT. NO CURRENT DMS DATA IS AVAILABLE, AS THE USER'S SYSTEM REACHED END OF LIFE ON (B)(6) 2024. PER DMS, THE USER HAS NOT USED THE SYSTEM SINCE WEDNESDAY, (B)(6) 2024 AT 8:53 AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622945 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR QHJ SENSEONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization