BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERSENSE SENSOR

    MDR report key: 22767535 · Received August 9, 2025

    Report

    Report Number
    3009862700-2025-01146
    Event Type
    Malfunction
    Date Received
    August 9, 2025
    Date of Event
    July 10, 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 CUSTOMER COMPLAINED OF RECEIVING "NEW SENSOR DETECTED" ALERT UNEXPECTEDLY. THE CUSTOMER WAS ASKED TO PERFORM A TRANSMITTER DIAGNOSTIC LOG FOR FURTHER REVIEW. BASED ON THE REVIEW OF TRANSMITTER DIAGNOSTIC LOG, IT WAS DETERMINED THAT THE TRANSMITTER WAS DETECTING TWO SENSORS (SN (B)(6) AND SN (B)(6)). IF MULTIPLE SENSORS ARE PRESENT IN CLOSE PROXIMITY TO THE CURRENT SENSOR, THIS COULD RESULT IN SIGNAL INTERFERENCE, PREVENTING THE NORMAL SYSTEM USAGE. THE CUSTOMER WAS THEREFORE ADVISED TO CONTACT THEIR HCP TO DISCUSS THE POSSIBILITY OF REMOVING OLD SENSOR OR BOTH SENSORS, AND TO GET INSERTED WITH A NEW ONE IN ANOTHER POCKET, PREFERABLY IN THE OPPOSITE ARM. H6. TYPE OF INVESTIGATION UPDATED TO 4121. H6. INVESTIGATION FINDINGS UPDATED TO 114. H6. INVESTIGATION CONCLUSIONS UPDATED TO 24.

    Additional Manufacturer Narrative · 0

    D2B.CORRECTED FROM SBA TO QHJ.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER IS CURRENTLY PERFORMING INVESTIGATION AND THE RESULTS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER REPORTED RECEIVING MULTIPLE "NEW SENSOR DETECTED" ALERTS UNEXPECTEDLY. THE ISSUE WAS ESCALATED TO NEXT LEVEL SUPPORT WHO DETERMINED THE PRESENCE OF ANOTHER SENSOR IN THE CLOSE PROXIMITY, INTERFERING THE NORMAL SYSTEM PERFORMANCE. THE USER WAS REDIRECTED TO HCP TO DISCUSS ABOUT NEXT STEPS, SUCH AS REMOVAL AND REPLACEMENT OF THE OLDER SENSOR OR BOTH THE SENSORS IF UNABLE TO REMOVE THE OLDER SENSOR. THE ISSUE DID NOT LEAD TO ANY ADVERSE EVENT NOR CAUSED ANY PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565274 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR QHJ SENSEONICS INC. 101967-950 2000187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown