BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 21360958 · Received February 11, 2025

    Report

    Report Number
    3009862700-2025-00115
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    January 13, 2025
    Report Date
    January 15, 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

    THE SENSOR REPLACEMENT ALERT WAS FIRST PRESENTED TO THE USER ON (B)(6) 2024, DAY 61 AFTER INSERTION. THE RMA WAS ISSUED FOR FURTHER INVESTIGATION OF THE SENSOR.HOWEVER,IT WAS NOT POSSIBLE TO TEST THE RETURNED SENSOR DUE TO HYDROGEL COMPLETELY MISSING OVER THE OPTICS. HE DAMAGE OBSERVED ON THE HYDROGEL IS MOST LIKELY CAUSED BY EXCESSIVE FORCE APPLIED BY THE REMOVAL CLAMPS DURING THE EXPLANT OF THE SENSOR AND IS NOT RELATED TO THE CUSTOMER'S ISSUE.A REVIEW OF THE IN VIVO DATA FROM DMS SHOWED DIMINISHED SENSOR PERFORMANCE AS THE SIGNAL STEADILY DECLINED AND THE MSP GRADUALLY DECREASED TO THE THRESHOLD VALUE THROUGHOUT THE INSERTION PERIOD. THIS IS INDICATIVE OF HYDROGEL OXIDATION AND THE SYSTEM CORRECTLY DISABLED THE SENSOR DUE TO PERFORMANCE FAILURE.AS PART OF RESOLUTION, A RETURN MATERIAL AUTHORIZATION WAS ISSUED FOR SENSOR REPLACEMENT. B4.DATE OF THIS REPORT 10 APRIL 2025. G3.DATE RECEIVED BY THE MANUFACTURER? 10 APRIL 2025. H3. DEVICE EVALUATED BY MANUFACTURER? YES. H6. MEDICAL DEVICE PROBLEM CODE UPDATED TO 1480. H6. TYPE OF INVESTIGATION UPDATED TO 10. H6. INVESTIGATION FINDINGS UPDATED TO 3231. H6. INVESTIGATION CONCLUSIONS UPDATED TO 4307.

    Additional Manufacturer Narrative · 0

    D2B.CORRECTED FROM SBA TO QHJ.

    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

    ON FFEBRUARY 13, 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442435 EVERSENSE SENSOR EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM QHJ SENSEONICS INC. 101967-931 WP09925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown