BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 22723165 · Received August 5, 2025

    Report

    Report Number
    3009862700-2025-01152
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 7, 2025
    Report Date
    October 4, 2025
    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 MANUFACTURER IS CURRENTLY PERFORMING INVESTIGATION AND THE RESULTS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025, THE USER REPORTED THAT THE CGM RESULTS DIFFERED FROM GLUCOMETER MEASUREMENTS. FOLLOWING ESCALATION, A SENSOR REPLACEMENT WAS APPROVED, AND AN RMA WAS ISSUED FOR INVESTIGATION. FUNCTIONAL TESTING OF THE RETURNED SENSOR DID NOT IDENTIFY ANY MALFUNCTION; HOWEVER, DMS DATA REVIEW SHOWED INSTABILITY IN THE REFERENCE CHANNEL, WHICH LIKELY CONTRIBUTED TO THE REPORTED INACCURACIES. THE POTENTIAL ROOT CAUSE MAY BE RELATED TO THE IN VIVO CONDITION OF THE SENSOR HYDROGEL, WHICH COULD NOT BE REPLICATED IN LABORATORY TESTING. THE RMA WAS AUTHORIZED TO PROVIDE THE USER WITH A REPLACEMENT SENSOR. B4. DATE OF THIS REPORT 04 OCT 2025. G3. DATE RECEIVED BY THE MANUFACTURER? 04 OCT 2025. H3. DEVICE EVALUATED BY MANUFACTURER? YES. H6. TYPE OF INVESTIGATION UPDATED TO 10,4121. H6. INVESTIGATION FINDINGS UPDATED TO 3224. H6. INVESTIGATION CONCLUSIONS UPDATED TO 4315.

    Description of Event or Problem · 0

    ON 07 JULY 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE PATIENT COMPLAINED OF INACCURATE SENSOR READING THE PATIENT OBSERVED MEASUREMENT DEVIATIONS BETWEEN CGM AND BLOOD GLUCOSE (BG), BUT DID NOT PROVIDE ANY SPECIFIC EXAMPLES FOR REVIEW. THE ISSUE WAS ESCALATED TO NEXT LEVEL SUPPORT WHO REVIEWED THE SYSTEM PERFORMANCE IN DATA MANAGEMENT SYSTEM (DMS) AND 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
    1288839 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR QHJ SENSEONICS INC. 101967-950 WP09963

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown