BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 20918509 · Received December 12, 2024

    Report

    Report Number
    3009862700-2024-01084
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 13, 2024
    Report Date
    April 17, 2025
    Manufacturer
    SENSEONICS INC.
    Product Code
    QCD
    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

    THE INITIAL INVESTIGATION WAS PERFORMED ON THE CUSTOMER SYNCED GLUCOSE DATA IN DATA MANAGEMENT SYSTEM (DMS), WHICH IS A CLOUD PLATFORM FOR EVERSENSE SYSTEMS. THE INITIAL ESCALATION ANALYSIS REVEALED THAT THE SYSTEM PERFORMANCE HAD DEVIATED FROM NORMAL BEHAVIOR. TO FURTHER INVESTIGATE, A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO BRING THE SENSOR BACK. THE RETURNED SENSOR WAS VISUALLY INSPECTED WHICH REVEALED THAT A PORTION OF THE SENSOR'S CHEMICAL COMPONENT (HYDOGEL) WAS MISSING FROM THE SENSOR'S OPTICS AND BACK OF THE SENSOR. THIS MISSING HYDROGEL IS MOST LIKELY DUE TO DAMAGE CAUSED BY EXCESSIVE FORCE APPLIED BY THE REMOVAL CLAMPS UPON EXPLANT OF THE SENSOR AND IS UNRELATED TO THE USER'S COMPLAINT. FUNCTIONAL TESTING OF THE RETURNED SENSOR DID NOT REVEAL ANY MALFUNCTION. THUS, THE INVESTIGATION WAS INCONCLUSIVE. THIS HAPPENS IN CERTAIN CASES WHERE THE FAILURE MODE THAT PRESENTS ITSELF WITHIN THE BODY, CANNOT BE REPRODUCED IN THE LAB. A FURTHER ANALYSIS OF THE SENSOR RAW DATA SHOWED SIGNIFICANTLY DEPRESSED AND UNSTABLE SIGNAL AND REFERENCE CHANNEL VALUES AND DECLINING SENSOR PERFORMANCE. THE POTENTIAL ROOT CAUSE FOR THE FAILURE MODE MAY BE RELATED TO AN ISSUE WITH THE IN-VIVO STATE OF SENSOR'S CHEMICAL COMPONENT, SUCH AS HYDROGEL INTERFACE BEING INTERFERED WITH COAGULATED BLOOD AT THE INSERTION SITE, RESULTING FROM INSERTION PROCEDURE. B4. DATE OF THIS REPORT 17 APRIL 2025. G3. DATE RECEIVED BY THE MANUFACTURER? 17 APRIL 2025. H3. DEVICE EVALUATED BY MANUFACTURER? YES. D9 DEVICE AVAILABLE FOR EVALUATION? YES ON 24 JAN 2025. H6. TYPE OF INVESTIGATION UPDATED TO 10. H6. INVESTIGATION FINDINGS UPDATED TO 114. 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 SENSOR GLUCOSE (SG) AND BLOOD GLUCOSE (BG) METER READINGS. THE PATIENT PROVIDED THE BELOW SET OF EXAMPLES. DATE, TIME, SG VALUE, BG VALUE A. ON (B)(6) 2024, 18.00 350 MG/DL 98 MG/DL, B. ON (B)(6) 2024, 10.40 68 MG/DL 115 MG/DL, C. ON (B)(6) 2024, 13.00 95 MG/DL 130 MG/DL, D. ON (B)(6) 2024, 05:30 AM CET 107 MG/DL 193 MG/DL, E. ON (B)(6) 2024, 04:30 PM CET 166 MG/DL 102 MG/DL, F. ON (B)(6) 2024, 05:50 PM CET 69 MG/DL 136 MG/DL, G. ON (B)(6) 2024, 06:10 AM CET 139 MG/DL 99 MG/DL. THE ISSUE WAS ESCALATED TO NEXT LEVEL SUPPORT WHO 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
    1857831 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR QCD SENSEONICS INC. 101967-950 WP09925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown