BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 22491185 · Received July 13, 2025

    Report

    Report Number
    3009862700-2025-00956
    Event Type
    Malfunction
    Date Received
    July 13, 2025
    Date of Event
    June 13, 2025
    Report Date
    September 10, 2025
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    PMA / PMN Number
    P160048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ON THE ON (B)(6) 2025, THE USER REPORTED THAT THE SYSTEM SHOWED RESULTS THAT WERE DIFFERENT FROM GLUCOMETER MEASUREMENTS. BASED ON THE ESCALATION ANALYSIS IT WAS DETERMINED THAT THE SENSOR HAD DEVIATED FROM NORMAL BEHAVIOR, A SENSOR REPLACEMENT WAS APPROVED, AND AN RMA WAS ISSUED FOR FURTHER INVESTIGATION. THE SENSOR WAS RETURNED FOR FURTHER INVESTIGATION, AND UPON RECEIPT, A VISUAL INSPECTION SHOWED NO ANOMALIES ON THE SENSOR. A REVIEW OF THE RAW SENSOR DATA ALSO REVEALED OPTICAL INSTABILITY, HOWEVER, THIS COULD NOT BE REPRODUCED DURING IN-HOUSE TESTING. THIS MAY OCCUR IN SOME INSTANCES WHERE THE FAILURE MODE THAT PRESENTS ITSELF IN THE BODY IS NOT REPRODUCED IN THE LAB, SUCH AS THE IN VIVO STATE OF THE SENSOR HYDROGEL. THE USER WAS OFFERED A SENSOR REPLACEMENT AS A RESOLUTION. B4. DATE OF THIS REPORT 10 SEPT 2025. G3. DATE RECEIVED BY THE MANUFACTURER? 10 SEPT 2025. H3. DEVICE EVALUATED BY MANUFACTURER? YES. H6. TYPE OF INVESTIGATION UPDATED TO 10. H6. INVESTIGATION FINDINGS UPDATED TO 3224. H6. INVESTIGATION CONCLUSIONS UPDATED TO 4315.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE PATIENT COMPLAINED OF INACCURATE SENSOR READINGS. THE PATIENT OBSERVED MEASUREMENT DEVIATIONS BETWEEN CGM AND BLOOD GLUCOSE (BG) AND PROVIDED THE BELOW EXAMPLES. DATE TIME SG VALUE BG VALUE A. (B)(6) 2025 1:03 154 197, B. 13:40 103 126, C. 18:40 112 164, D. 19:40 105 159. 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
    1118793 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR QHJ SENSEONICS INC. 101967-950 WP09966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown