BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 22873346 · Received August 22, 2025

    Report

    Report Number
    3009862700-2025-01185
    Event Type
    Injury
    Date Received
    August 22, 2025
    Date of Event
    July 23, 2025
    Report Date
    September 6, 2025
    Manufacturer
    SENSEONICS INC.
    Product Code
    QHJ
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 USER REPORTED A LOW GLUCOSE EVENT ON 23-JUL-2025 AT 12:30 PM WHERE USER'S SG WAS 17 MG/DL AND BG WAS 48 MG/DL.A REVIEW OF THE DATA MANAGEMENT SYSTEM (DMS) REVEALED THAT ON JUL-23-2025 AT 12:25 PM SG: 117 MG/DL AND NO BG WAS ENTERED. A REVIEW OF THE ALERT HISTORY REVEALED THAT THE USER DID NOT RECEIVE A LOW GLUCOSE ALERT AROUND THE REPORTED TIME AS USER'S SG WAS ABOVE 65 MG/DL. THE USER DID NOT SEEK MEDICAL TREATMENT AND RESOLVED THE EVENT BY INGESTING GLUCOSE. USER'S HCP WAS NOT AWARE OF THE EVENT. THE USER WAS ADVISED TO FOLLOW UP WITH THE HCP FOR FURTHER MEDICAL GUIDANCE.A CASE WAS CREATED TO ADDRESS SENSOR INACCURACIES INCLUSIVE OF THE REPORTED LOW GLUCOSE EVENT. A REVIEW OF THE DMS DATA SHOWED VARIATION IN SENSOR VALUES, WHICH MAY BE DUE TO EARLY WEAR AND ADJUSTMENT OF THE SENSOR AFTER INSERTION. SOME SENSORS DO SHOW A LITTLE MORE VARIABILITY IN THE FIRST FEW DAYS AND THEN SETTLE DOWN TO GIVE THE TYPICAL PERFORMANCE. THE USER WAS ADVISED TO ALLOW THE SYSTEM A FEW MORE DAYS TO ADJUST, ENTERING ANY ADDITIONAL CALIBRATIONS AS REQUESTED BY THE SYSTEM. A REVIEW OF DATA FROM THE TWO WEEKS FOLLOWING THE EVENT CONFIRMED A GOOD AGREEMENT BETWEEN SG AND BG VALUES. B4.DATE OF THIS REPORT 06 SEPT 2025 G3.DATE RECEIVED BY THE MANUFACTURER? 06 SEPT 2025 H3. DEVICE EVALUATED BY MANUFACTURER? YES H6. TYPE OF INVESTIGATION UPDATED TO 4121 H6. INVESTIGATION FINDINGS UPDATED TO 3224. H6. INVESTIGATION CONCLUSIONS UPDATED TO 22.

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF HYPOGLYCEMIA EVENTS WHERE THE PATIENT DID NOT RECEIVE ALERTS FROM EVERSENSE CGM SYSTEM DUE TO POSSIBLE SENSOR INACCURACIES. THE EVENT DETAILS ARE AS FOLLOWS: ON (B)(6) 2025 12:30 PM (UTC+1) SG 117 MG/DL BG 48 MG/DL. THE PATIENT DID NOT SEEK MEDICAL ATTENTION AND WAS ABLE TO SELF RESOLVE THE EVENT BY EATING SUGAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2656395 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR QHJ SENSEONICS INC. 101967-950 2000675

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown