BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 23103231 · Received September 19, 2025

    Report

    Report Number
    3009862700-2025-01411
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    August 18, 2025
    Report Date
    January 15, 2026
    Manufacturer
    SENSEONICS, INC
    Product Code
    QHJ
    PMA / PMN Number
    P160048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 18TH AUG 2025, THE USER INFORMED SENSEONICS THAT THE CGM SHOWED RESULTS THAT WERE DIFFERENT FROM GLUCOMETER MEASUREMENTS. BASED ON THE ESCALATION ANALYSIS A SENSOR REPLACEMENT WAS APPROVED DUE TO SYSTEM PERFORMANCE, AND AN RMA WAS ISSUED FOR FURTHER INVESTIGATION. UPON RECEIPT, A VISUAL INSPECTION SHOWED A PORTION OF HYDROGEL WAS OBSERVED TO BE MISSING FROM THE LONG END OF THE SENSOR. THIS MISSING HYDROGEL IS MOST LIKELY DUE TO DAMAGE CAUSED BY EXCESSIVE FORCE APPLIED BY THE REMOVAL CLAMPS UPON EXPLANT OF THE SENSOR AND IS UNRELATED TO THE USER'S COMPLAINT. IN-HOUSE TESTING OF THE SENSOR SHOWED THAT THE SENSOR WAS CHEMICALLY UNDERPERFORMING. A REVIEW OF THE IN VIVO DATA FROM DMS SHOWED DIMINISHED SENSOR PERFORMANCE, CONSISTENT WITH OXIDATION OF THE GLUCOSE INDICATING COMPONENT OF THE SENSOR HYDROGEL, WHICH LIKELY CONTRIBUTED TO THE INACCURACIES OBSERVED BY THE USER. A REPLACEMENT SENSOR WAS PROVIDED TO THE USER AS PART OF THE RESOLUTION. B4. DATE OF THIS REPORT 18 NOV 2025. G3. DATE RECEIVED BY THE MANUFACTURER? 18 NOV 2025. H3. DEVICE EVALUATED BY MANUFACTURER? YES. H6. TYPE OF INVESTIGATION UPDATED TO 10. H6. INVESTIGATION FINDINGS UPDATED TO 3231. H6. INVESTIGATION CONCLUSIONS UPDATED TO 4307.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    D2B.CORRECTED FROM SBA TO QHJ.

    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) (B)(6). 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
    2843501 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR QHJ SENSEONICS, INC 101967-950 WP09972

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown