BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 23675599 · Received November 29, 2025

    Report

    Report Number
    3009862700-2025-01844
    Event Type
    Injury
    Date Received
    November 29, 2025
    Date of Event
    October 29, 2025
    Report Date
    November 27, 2025
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER'S REPRESENTATIVE REPORTED THAT THE USER WAS HOSPITALIZED DUE TO AN ILEUS AND WAS DIAGNOSED WITH ILEUS; THE EVENT OCCURRED WITHIN THE LAST FEW DAYS AND WAS NOT RELATED TO SENSOR INSERTION, SENSOR REMOVAL, OR DIABETES. CERTAIN DETAILS REMAIN UNAVAILABLE BECAUSE THE USER COULD NOT BE DIRECTLY CONTACTED, AND THE INFORMATION PROVIDED WAS LIMITED TO WHAT THE REPRESENTATIVE REPORTED. PER DMS REVIEW, THE USER IS CURRENTLY USING THE SYSTEM WITH UP-TO-DATE INFORMATION.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWAREOF AN INCIDENT WHERE USER'S REPRESENTATIVE REPORTED THAT THE USER WAS HOSPITALIZED DUE TO AN ILEUS AND WAS DIAGNOSED WITH ILEUS. THE EVENT OCCURRED WITHIN THE LAST FEW DAYS. THE EVENT WAS NOT RELATED TO SENSOR INSERTION OR REMOVAL AND WAS NOT RELATED TO DIABETES.CERTAIN DETAILS REMAIN UNAVAILABLE BECAUSE THE USER COULD NOT BE DIRECTLY CONTACTED. THE INFORMATION PROVIDED WAS LIMITED TO WHAT THE USER'S REPRESENTATIVE REPORTED.PER DMS REVIEW, THE USER IS CURRENTLY USING THE SYSTEM WITH UP-TO-DATE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2265713 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR QHJ SENSEONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization