BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 23858376 · Received December 20, 2025

    Report

    Report Number
    3009862700-2025-01957
    Event Type
    Malfunction
    Date Received
    December 20, 2025
    Date of Event
    November 19, 2025
    Report Date
    February 16, 2026
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    PMA / PMN Number
    P160048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    AN INITIAL INVESTIGATION WAS CONDUCTED USING THE GLUCOSE DATA SYNCED BY THE CUSTOMER TO THE DATA MANAGEMENT SYSTEM (DMS), THE CLOUD-BASED PLATFORM SUPPORTING THE EVERSENSE SYSTEM. THE ANALYSIS INDICATED THAT SYSTEM PERFORMANCE HAD DEVIATED FROM EXPECTED BEHAVIOR. TO FURTHER INVESTIGATE THE ISSUE AND IDENTIFY THE ROOT CAUSE, A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO RETRIEVE THE SENSOR FOR EVALUATION. HOWEVER, THE SENSOR WAS NOT RECEIVED. A FURTHER REVIEW OF THE IN-VIVO RAW SENSOR DATA REVEALED OPTICAL INSTABILITY AROUND THE TIME-FRAME OF THE REPORTED INACCURACIES. IN AN ASSOCIATED COMPLAINT (MFR#3009862700-2025-02033), THE CUSTOMER REPORTED INFECTION AT THE INSERTION SITE, FIRST OBSERVED ON 23-NOV-2025, WITH SYMPTOMS OF SWELLING, PAIN AND FORMATION OF PUS. THE ONSET OF THIS INFECTION LIKELY CONTRIBUTED TO OPTICAL INSTABILITY AND THE RESULTING INACCURACIES. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT SENSOR AS PART OF THE RESOLUTION. B4.DATE OF THIS REPORT 16 FEB 2026. G3.DATE RECEIVED BY THE MANUFACTURER? 16 FEB 2026. H3. DEVICE EVALUATED BY MANUFACTURER?YES. H6. TYPE OF INVESTIGATION UPDATED TO 4114,4121. H6. INVESTIGATION FINDINGS UPDATED TO 3224. H6. INVESTIGATION CONCLUSIONS UPDATED TO 4310,22.

    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 EXPERIENCED SENSOR INACCURACY WHICH LED TO EARLY SENSOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135540 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR QHJ SENSEONICS INC. 101967-950 2001020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown