BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 23892611 · Received December 25, 2025

    Report

    Report Number
    3009862700-2025-01980
    Event Type
    Injury
    Date Received
    December 25, 2025
    Date of Event
    November 25, 2025
    Report Date
    January 15, 2026
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    UDI-DI
    00817491022950
    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

    THE USER REPORTED GOING TO THE ER DUE TO PAIN AND BLEEDING AT THE SENSOR SITE, WHICH OCCURRED ON (B)(6) 2025; ACCORDING TO THE USER, THE INCISION HAD REOPENED WITH BLOOD DISCHARGE, AND THEY FELT AS THOUGH THE SENSOR WAS COMING OUT OF THEIR ARM ON ITS OWN, PROMPTING THE ER VISIT, ALTHOUGH AT THE TIME OF THE CALL THE USER WAS FEELING OKAY. THE EVENT WAS NOT RELATED TO SENSOR INSERTION OR REMOVAL BUT WAS RELATED TO THE EVERSENSE SYSTEM. THE USER DID NOT RECEIVE TREATMENT AT THE HOSPITAL AND WAS NOT PRESCRIBED ANY MEDICATION. THE USER'S HCP IS AWARE OF THE EVENT, AND THE USER WAS ADVISED TO CONTINUE FOLLOWING UP WITH THE HCP FOR FURTHER MEDICAL GUIDANCE. PER DMS, THE USER HAS NOT BEEN USING THE SYSTEM SINCE (B)(6) 2024 AT 8:53 AM DUE TO THE SENSOR REACHING END OF LIFE.

    Additional Manufacturer Narrative · 0

    D2B.CORRECTED FROM SBA TO QHJ.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED GOING TO THE ER DUE TO PAIN AND BLEEDING AT THE SENSOR SITE, WHICH OCCURRED ON (B)(6) 2025; ACCORDING TO THE USER, THE INCISION HAD REOPENED WITH BLOOD DISCHARGE, AND THEY FELT AS THOUGH THE SENSOR WAS COMING OUT OF THEIR ARM ON ITS OWN, PROMPTING THE ER VISIT, ALTHOUGH AT THE TIME OF THE CALL THE USER WAS FEELING OKAY. THE EVENT WAS NOT RELATED TO SENSOR INSERTION OR REMOVAL BUT WAS RELATED TO THE EVERSENSE SYSTEM. THE USER DID NOT RECEIVE TREATMENT AT THE HOSPITAL AND WAS NOT PRESCRIBED ANY MEDICATION. THE USER'S HCP WAS AWARE OF THE EVENT, AND THE USER WAS ADVISED TO CONTINUE FOLLOWING UP WITH THE HCP FOR FURTHER MEDICAL GUIDANCE. PER DMS, THE USER HAS NOT BEEN USING THE SYSTEM SINCE (B)(6) 2024 AT 8:53 AM DUE TO THE SENSOR REACHING END OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478381 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR QHJ SENSEONICS INC. 102096-81A WP09620 00817491022950

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization