BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 21554201 · Received March 7, 2025

    Report

    Report Number
    3009862700-2025-00270
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    February 5, 2025
    Report Date
    May 3, 2025
    Manufacturer
    SENSEONICS INC.
    Product Code
    SBA
    UDI-DI
    00817491024282
    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 USER COMPLAINED ABOUT RECEIVING A SENSOR CHECK ALERT AND THE APP IS NOT DISPLAYING VALUES ON (B)(6) 2025, 51 DAYS AFTER INSERTION. IN-HOUSE TESTING OF SENSOR WAS NOT POSSIBLE AS THE SENSOR WAS BROKEN. IT IS NOT CLEAR WHEN THE SENSOR GOT BROKEN (DURING EXPLANT PROCEDURE OR DURING TRANSPORTATION). IF THE SENSOR BREAKAGE HAPPENED DURING THE EXPLANT PROCEDURE, THEN IT WAS MOST LIKELY CAUSED BY EXCESSIVE FORCE APPLIED BY THE REMOVAL CLAMPS TO THE EXTREMITIES OF THE SENSOR DURING THE EXPLANT OF THE SENSOR. THE USER STARTED RECEIVING SENSOR CHECK ALERT ON (B)(6) 2025 AT 3:55AM. A REVIEW OF THE ALERT HISTORY SHOWS THAT GLUCOSE SUSPEND ALERT WAS ALSO TRIGGERED AT 3:55AM, BLINDING THE SENSOR GLUCOSE. THE GLUCOSE SUSPEND ALERT/ GLUCOSE BLINDING WAS DUE TO A KNOWN, BUG. A REVIEW OF THE RAW SENSOR DATA SHOWED REFERENCE CHANNEL INSTABILITY IN THE UV NORM AND BLUE NORM, TRIGGERING THE SENSOR CHECK ALERT. AS PART OF RESOLUTION, A RETURN MATERIAL AUTHORIZATION WAS ISSUED FOR SENSOR REPLACEMENT. B4. DATE OF THIS REPORT 03 MAY 2025. G3.DATE RECEIVED BY THE MANUFACTURER? 03 MAY 2025. H3. DEVICE EVALUATED BY MANUFACTURER? YES. H6. MEDICAL DEVICE PROBLEM CODE UPDATED TO 3005. H6. TYPE OF INVESTIGATION UPDATED TO 10. H6. INVESTIGATION FINDINGS UPDATED TO 3224. 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.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED OF RECEIVING A SENSOR CHECK ALERT AND THE APP IS NOT DISPLAYING VALUES. AFTER DMS REVIEW, WE CONFIRMED THAT THE USER RECEIVED A SENSOR CHECK ALERT ON (B)(6) 2025 AT 3:55 AM. AS PER NOTES, THE USER WAS ASSISTED WITH THE TRANSMITTER FW UPGRADE, WHICH SENT THE SYSTEM BACK INTO INITIALIZATION PHASE. THE SENSOR WILL BE REPLACED WITH RETURN OF PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139067 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR SBA SENSEONICS INC. 103606-600 02E296S 00817491024282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown