BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 23736032 · Received December 8, 2025

    Report

    Report Number
    3009862700-2025-01839
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    November 4, 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
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D2B.CORRECTED FROM SBA TO QHJ. H1 TYPE OF REPORTABLE EVENT CORRECTED TO SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    THE USER REPORTED AN UNSUCCESSFUL REMOVAL ATTEMPT OF SENSOR ON (B)(6) 2025 AT 1:30 PM. THE SENSOR WAS LOCATED IN THE RIGHT UPPER ARM. IT WAS CONFIRMED THAT AN INCISION WAS MADE DURING THE REMOVAL ATTEMPT. AT THE TIME OF THE CALL, THE USER REPORTED DOING WELL. THE SENSOR WAS NOT PALPABLE PRIOR TO THE INCISION. A TRANSMITTER, ULTRASOUND, AND A MAGNET WERE EACH USED IN ATTEMPTS TO LOCALIZE THE SENSOR. THE NEXT TENTATIVE REMOVAL DATE IS (B)(6) 2026. A FOLLOW-UP WILL BE CONDUCTED AFTER THAT DATE TO CONFIRM WHETHER THE SENSOR WAS SUCCESSFULLY REMOVED. PER DMS, THE USER IS CURRENTLY USING THE SYSTEM WITH A NEW SENSOR AND IS RECEIVING UP-TO-DATE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232852 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR QHJ SENSEONICS INC. 101967-950 WP09972

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown