BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 21997862 · Received May 9, 2025

    Report

    Report Number
    3009862700-2025-00628
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    April 9, 2025
    Report Date
    May 23, 2025
    Manufacturer
    SENSEONICS INC.
    Product Code
    SBA
    UDI-DI
    00817491024282
    PMA / PMN Number
    P160048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER IS CURRENTLY PERFORMING AN INVESTIGATION AND WILL PROVIDE THE RESULTS WITH THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE USER REPORTED A LOW GLUCOSE EVENT. THE FOLLOWING EXAMPLE SET WAS PROVIDED: 1.(B)(6) 2025 1:16 PM CST/ SG: 47 MG/DL - BG: 68 MG/DL, 2.(B)(6) 2025 3:21 PM CST/ SG: 75 MG/DL - BG: 134 MG/DL. A REVIEW OF THE DATA MANAGEMENT SYSTEM (DMS) REVEALED THAT ON (B)(6) 2025 1:16 PM CST/ SG: 47 MG/DL AND NO BG WAS ENTERED. ON (B)(6) 2025 3:21 PM CST/ SG: 75 MG/DL AND NO BG WAS 134 MG/DL. A REVIEW OF THE ALERT HISTORY REVEALED THAT THE USER RECEIVED MULTIPLE LOW GLUCOSE ALERTS AROUND REPORTED TIME. THE USER DID NOT SEEK MEDICAL TREATMENT AND RESOLVED THE EVENT BY EATING SOMETHING. USER'S HCP WAS NOT AWARE OF THE EVENT. THE USER WAS ADVISED TO GET IN TOUCH WITH THEIR HCP FOR MEDICAL GUIDANCE. AN CASE (B)(4) WAS CREATED TO ADDRESS SENSOR INACCURACIES INCLUSIVE OF THE REPORTED EVENT. A REVIEW OF THE IN-VIVO DATA REVEALED DEPRESSED SIGNAL AND REFERENCE CHANNELS SINCE INSERTION ON (B)(6) 2025. THE SYSTEM WAS IN THE PROCESS OF GETTING STABILIZED FROM INSERTION ON (B)(6) 2025. THIS OBSERVED INSTABILITY MOST LIKELY CONTRIBUTED TO THE SG/BG MISMATCH AT THE TIME OF THE EVENT. THE POTENTIAL ROOT CAUSE FOR THIS MAY BE RELATED TO AN ISSUE WITH THE IN VIVO STATE OF THE SENSOR HYDROGEL, SUCH AS THE HYDROGEL INTERFACE BEING INTERFERED WITH COAGULATED BLOOD AT THE INSERTION SITE FROM THE INSERTION PROCEDURE. A REVIEW OF 2 WEEKS((B)(6) 2025 - (B)(6) 2025) DATA POST RECOVERY WAS ANALYZED AND THE SYSTEM STARTED DISPLAYING BETTER AGREEMENT BETWEEN THE SENSOR READINGS AND FINGERSTICK MEASUREMENTS, AND BEGAN TO PERFORM WITHIN EXPECTATIONS. H3. DEVICE EVALUATED BY MANUFACTURER?YES. H6. HEALTH EFFECT - CLINICAL CODE UPDATED TO 4582, H6. HEALTH EFFECT -IMPACT CODE UPDATED TO 2199, H6. TYPE OF INVESTIGATION UPDATED TO 4121, H6. INVESTIGATION FINDINGS UPDATED TO 114, H6. INVESTIGATION CONCLUSIONS UPDATED TO 4315.

    Description of Event or Problem · 0

    ON 09 APRIL 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED HYPOGLYCEMIC EVENTS ON (B)(6) 2025. THE BELOW EXAMPLES WERE PROVIDED BY THE USER: ON (B)(6) 2025 AT 01:16 PM USER'S BG WAS 68 MG/DL AND SG WAS 47 MG/DL. ON (B)(6) 2025 AT 03:21 PM USER'S BG WAS 134 MG/DL AND SG WAS 75 MG/DL. FOR EXAMPLE 1, SG WAS CONFIRMED IN DMS. NO BG WAS ENTERED AT THAT TIME. FOR EXAMPLE 2, BOTH THE SG AND BG WERE CONFIRMED IN DMS. THE USER RECEIVED LOW GLUCOSE ALERTS IN BOTH INSTANCES.THE USER ATE SOMETHING FOR FIRST EXAMPLE AND FOR THE SECOND EXAMPLE USER DID NOT TREAT AFTER CHECKING HIS BG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217525 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR SBA SENSEONICS INC. 103606-600 03F056S 00817491024282

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male