BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 21289889 · Received February 3, 2025

    Report

    Report Number
    3009862700-2025-00055
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    December 31, 2024
    Report Date
    January 15, 2026
    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 SENSOR REPLACEMENT ALERT WAS FIRST PRESENTED TO THE USER ON (B)(6) 2024, DAY 21 AFTER INSERTION. THE RMA WAS AUTHORIZED FOR THE RETURN OF SENSOR FOR FURTHER INVESTIGATION.THE SENSOR WAS RETURNED AND TESTED IN-HOUSE, AND THE REVIEW OF INVESTIGATION ANALYSIS DID NOT REVEAL ANY MALFUNCTION OF THE SENSOR. THIS MAY OCCUR IN SOME INSTANCES WHERE THE FAILURE MODE THAT PRESENTS ITSELF IN THE BODY IS NOT REPRODUCED IN THE LAB. A REVIEW OF THE RAW SENSOR DATA SHOWED SIGNIFICANTLY LOW SIGNAL AND REFERENCE CHANNELS. THIS MOST LIKELY CAUSED THE MSP VALUES TO STAY BELOW THE THRESHOLD VALUE, AND THEREBY TRIGGERING THE SENSOR REPLACEMENT ALERT ON DAY 21 AFTER SENSOR INSERTION. THIS IS POTENTIALLY DUE TO COAGULATED BLOOD FROM THE IMPLANT PROCESS INTERFERING WITH THE INTERFACE OF THE HYDROGEL.AS PART OF RESOLUTION, THE RMA WAS AUTHORIZED FOR SENSOR REPLACEMENT. B4. DATE OF THIS REPORT 01 APRIL 2025. D9. DEVICE AVAILABLE FOR EVALUATION? YES, ON 05 FEB 2025. G3. DATE RECEIVED BY THE MANUFACTURER? 01 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 (B)(6) 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
    350443 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR QHJ SENSEONICS INC. 101967-950 WP09925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown