BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 22163741 · Received June 7, 2025

    Report

    Report Number
    3009862700-2025-00745
    Event Type
    Injury
    Date Received
    June 7, 2025
    Date of Event
    April 22, 2025
    Report Date
    January 15, 2026
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    UDI-DI
    00817491022974
    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

    INABILITY OR DIFFICULTY TO REMOVE SENSOR DURING FIRST ATTEMPT IS A KNOWN AND ANTICIPATED POTENTIAL RISK AND EVERSENSE E3 USER GUIDE MENTIONS ABOUT IT UNDER "RISKS AND SIDE EFFECTS". FOR THIS INCIDENT, IT WAS REPORTED THAT HCP WAS UNABLE TO REMOVE THE SENSOR ON THE FIRST ATTEMPT MADE ON (B)(6) 2025. A SECOND REMOVAL ATTEMPT WAS ALSO DONE ON (B)(6) 2025, WHICH WAS ALSO UNSUCCESSFUL.THE SENSOR WAS PALPABLE BEFORE THE INCISION. TRANSMITTER WASN'T USED TO LOCALIZE THE SENSOR. ULTRASOUND WAS USED TO LOCALIZE THE SENSOR. THE SENSOR WAS SUCCESSFULLY REMOVED ON THE THIRD REMOVAL ATTEMPT ON (B)(6) 2025. AS PER (B)(6), USER IS NOT USING THE SYSTEM AS NO NEW SENSOR WAS INSERTED.

    Additional Manufacturer Narrative · 0

    D2B.CORRECTED FROM SBA TO QHJ.

    Description of Event or Problem · 0

    ON 08 MAY SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED UNSUCCESSFUL REMOVAL ATTEMPT OF THE SENSOR ON (B)(6) 2025. A SECOND REMOVAL ATTEMPT WAS ALSO DONE ON (B)(6) 2025, WHICH WAS ALSO UNSUCCESSFUL. SENSOR WAS PALPABLE BEFORE THE INCISION. TRANSMITTER WASN'T USED TO LOCALIZE THE SENSOR. ULTRASOUND WAS USED TO LOCALIZE THE SENSOR.THE SENSOR WAS SUCCESSFULLY REMOVED ON THE THIRD REMOVAL ATTEMPT ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249836 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR QHJ SENSEONICS INC. 102812-81A 03E221S 00817491022974

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male