BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 23332880 · Received October 18, 2025

    Report

    Report Number
    3009862700-2025-01694
    Event Type
    Malfunction
    Date Received
    October 18, 2025
    Date of Event
    September 18, 2025
    Report Date
    December 17, 2025
    Manufacturer
    SENSEONICS INC.
    Product Code
    SBA
    UDI-DI
    00817491024305
    PMA / PMN Number
    P160048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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

    ON 18TH SEPTEMBER 2025, THE USER INFORMED SENSEONICS THAT THE SYSTEM WAS DISPLAYING RESULTS THAT DIFFERED FROM BLOOD GLUCOMETER MEASUREMENTS. BASED ON THE ESCALATION ANALYSIS, A SENSOR REPLACEMENT WAS APPROVED DUE TO SYSTEM PERFORMANCE DEVIATION. AN RMA WAS ISSUED FOR THE RETURN OF THE SENSOR FOR FURTHER INVESTIGATION. UPON RECEIPT, VISUAL INSPECTION REVEALED A SMALL PORTION OF THE HYDROGEL MISSING OVER THE OPTICAL AREA OF THE SENSOR, LIKELY CAUSED DURING THE REMOVAL PROCEDURE DUE TO EXCESSIVE FORCE APPLIED BY THE REMOVAL CLAMPS; THIS FINDING WAS UNRELATED TO THE USER'S COMPLAINT. THIS DID NOT AFFECT THE FUNCTIONAL TESTING OF THE SENSOR, AS THE MAJORITY OF THE HYDROGEL REMAINED INTACT. IN-HOUSE TESTING IDENTIFIED DEGRADATION IN THE SENSOR CHEMICAL PERFORMANCE IN TWO SENSING AREAS, CONSISTENT WITH OXIDATION OF THE GLUCOSE-INDICATING COMPONENT OF THE SENSOR HYDROGEL. THIS FINDING WAS CONSISTENT WITH THE SENSOR IN VIVO DATA, WHICH SHOWED DECLINING SENSOR RESPONSE IN THE SAME AREAS, WHICH WERE APPROPRIATELY DE-WEIGHTED BY THE SYSTEM. ADDITIONALLY, A REVIEW OF THE IN-VIVO DATA INDICATED FREQUENT MISSED READS DUE TO INTERNAL ELECTRICAL COMMUNICATION ISSUES CONTRIBUTING TO THE NOISY/INACCURATE SENSOR GLUCOSE READINGS. AS PART OF THE RESOLUTION, THE USER WAS OFFERED A SENSOR REPLACEMENT. B4: DATE OF THIS REPORT 17 DEC 2025. D4: ADDITIONAL DEVICE INFORMATION UPDATED. G3: DATE RECEIVED BY THE MANUFACTURER? 17 DEC 2025. H3: DEVICE EVALUATED BY MANUFACTURER? YES. H6: TYPE OF INVESTIGATION UPDATED TO 10, 4121. H6: INVESTIGATION FINDINGS UPDATED TO 3231, 628. H6: INVESTIGATION CONCLUSIONS UPDATED TO 4307.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED SENSOR INACCURACY WHICH LED TO EARLYSENSOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566783 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR SBA SENSEONICS INC. 103606-620 01F034S 00817491024305

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female