BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SMART TRANSMITTER

    MDR report key: 21841859 · Received April 15, 2025

    Report

    Report Number
    3009862700-2025-00484
    Event Type
    Injury
    Date Received
    April 15, 2025
    Date of Event
    March 19, 2025
    Report Date
    June 16, 2025
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    PMA / PMN Number
    P160048
    Adverse Event
    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. BASED ON INITIAL INVESTIGATION ANALYSIS, THE SYSTEM WAS PERFORMING WITHIN EXPECTATIONS. OVERALL, THE BLOOD GLUCOSE (BG) INPUTS MET SENSOR GLUCOSE (SG) TRENDS WELL. THE INACCURACY EXAMPLE SHARED BY THE CUSTOMER SHOWED LAG, WHICH IS INHERENT TO ANY CGM SYSTEM. THE SG VALUE EVENTUALLY CAUGHT UP TO THE CALIBRATION ENTRY IN 3-4 READINGS. IT WAS ALSO OBSERVED THAT SOME CALIBRATIONS WERE ENTERED AFTER GAPS IN THE GLUCOSE DATA. THE CUSTOMER MAY EXPERIENCE LESS LAG BY ALLOWING THE SYSTEM TO DISPLAY 1-2 SG READINGS AFTER A GAP BEFORE ENTERING A CALIBRATION. CUSTOMER WAS ADVISED TO KEEP USING THE SYSTEM, ENTERING CALIBRATIONS AS REQUESTED. TWO WEEKS' (B)(6) 2025) WORTH OF DATA POST-EVENT WAS ANALYZED, AND THE SYSTEM CONTINUED TO SHOW GOOD SENSOR GLUCOSE/ BLOOD GLUCOSE AGREEMENT. THE CUSTOMER DID NOT EXPRESS ANY FURTHER CONCERNS. NO FURTHER INVESTIGATION WAS FOUND NECESSARY FOR THIS COMPLAINT. B4. DATE OF THIS REPORT 16 JUNE 2025. G3. DATE RECEIVED BY THE MANUFACTURER? 16 JUNE 2025. H3. DEVICE EVALUATED BY MANUFACTURER? YES. H6. TYPE OF INVESTIGATION UPDATED TO 4121. H6. INVESTIGATION FINDINGS UPDATED TO 213. H6. INVESTIGATION CONCLUSIONS UPDATED TO 22.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF A HYPERGLYCEMIA EVENT ON (B)(6) 2025 WITH BLOOD GLUCOSE (BG) VALUE OF 200 MG/DL AND SENSOR GLUCOSE (SG) VALUE OF 166 MG/DL. THE PATIENT COMPLAINED OF NOT RECEIVING HIGH GLUCOSE ALERTS. THE PATIENT SELF RESOLVED THE EVENT BY TAKING INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116503 EVERSENSE SMART TRANSMITTER IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER QHJ SENSEONICS INC. 102208-995 147689

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown