BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE E3 SENSOR

    MDR report key: 23613423 · Received November 20, 2025

    Report

    Report Number
    3009862700-2025-01854
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    October 3, 2025
    Report Date
    January 19, 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

    ON 21 OCT 2025, THE USER INFORMED SENSEONICS THAT THE CGM READINGS DIFFERED FROM GLUCOMETER MEASUREMENTS. THE CASE WAS ESCALATED TO THE NEXT LEVEL OF SUPPORT FOR FURTHER REVIEW. A REVIEW OF THE DATA MANAGEMENT SYSTEM (DMS) CONFIRMED THE USER HAD OPTED OUT OF DATA SHARING. THE USER PROVIDED A DIAGNOSTIC UPLOAD, WHICH WAS REVIEWED AND CONFIRMED INSTANCES OF INACCURACY. THE USER WAS ASSISTED WITH A SENSOR RE-LINK TO CLEAR THE HISTORICAL CALIBRATION BUFFER, AND THE SYSTEM WAS MONITORED FOR SEVERAL DAYS. THE USER LATER PROVIDED ADDITIONAL EXAMPLES AND A FOLLOW-UP DIAGNOSTIC UPLOAD AFTER THE RE-LINK; HOWEVER, THE ISSUE PERSISTED. BASED ON THE ESCALATION ANALYSIS, A SENSOR REPLACEMENT WAS APPROVED AND AN RMA WAS ISSUED FOR FURTHER INVESTIGATION. THE SENSOR WAS NOT RETURNED TO SENSEONICS BY THE TIME OF COMPLAINT CLOSURE.A REVIEW OF THE IN-VIVO DATA FROM THE CUSTOMER-PROVIDED DIAGNOSTIC UPLOAD DID NOT REVEAL ANY ANOMALIES IN THE RAW DATA. THE POTENTIAL ROOT CAUSE FOR THE REPORTED FAILURE MODE IS UNKNOWN; THE OBSERVED PERFORMANCE ISSUES ARE PRESUMED TO BE ASSOCIATED WITH THE IN-VIVO CONDITION OF THE SENSOR HYDROGEL. B4.DATE OF THIS REPORT 19 JAN 2026. G3.DATE RECEIVED BY THE MANUFACTURER? 19 JAN 2026. H3. DEVICE EVALUATED BY MANUFACTURER?YES. H6. TYPE OF INVESTIGATION UPDATED TO 4121. H6. INVESTIGATION FINDINGS UPDATED TO 114. H6. INVESTIGATION CONCLUSIONS UPDATED TO 4315.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER IS CURRENTLY PERFORMING INVESTIGATION AND THE RESULTS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE PATIENT COMPLAINED OF INACCURATE SENSOR READING THE PATIENT OBSERVED MEASUREMENT DEVIATIONS BETWEEN CGM AND BLOOD GLUCOSE (BG) AND PROVIDED THE BELOW EXAMPLES FOR REVIEW. DATE TIME SG VALUE (MG/DL) BG VALUE (MG/DL) A. (B)(6) 2025 / 12:25 PM / 153 / 111. B. (B)(6) 2025 / 12:20 PM / 155 / 110. C. (B)(6) 2025 / 03:00 PM / 142 / 114. D. (B)(6) 2025 / 03:20 PM / 160 / 120. THE ISSUE WAS ESCALATED TO NEXT LEVEL SUPPORT WHO REVIEWED THE SYSTEM PERFORMANCE IN DATA MANAGEMENT SYSTEM (DMS) AND AUTHORIZED A RETURN MATERIAL AUTHORIZATION (RMA) FOR THE SENSOR REPLACEMENT DUE TO POSSIBLE DEVIATION IN THE SYSTEM PERFORMANCE FROM THE NORMAL BEHAVIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2022933 EVERSENSE E3 SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR QHJ SENSEONICS INC. 101967-950 2001020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown