BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERSENSE SENSOR

    MDR report key: 22930265 · Received September 2, 2025

    Report

    Report Number
    3009862700-2025-01300
    Event Type
    Injury
    Date Received
    September 2, 2025
    Date of Event
    July 31, 2025
    Report Date
    January 7, 2026
    Manufacturer
    SENSEONICS INC.
    Product Code
    SBA
    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 USER REPORTED EXPERIENCING A HIGH GLUCOSE EVENT AND PROVIDED AN EXAMPLE FROM 31-JUL-2025 AT 7:45 AM CT WITH SG 68 MG/DL AND BG 337 MG/DL. REVIEW OF THE DATA MANAGEMENT SYSTEM (DMS) CONFIRMED GLUCOSE ALERT SETTINGS OF LOW ALERT AT 55 MG/DL AND HIGH ALERT AT 250 MG/DL. DMS DATA REVIEW SHOWED THAT ON 31-JUL-2025 AT 8:42 AM, THE USER'S SG WAS 68 MG/DL AND BG WAS 337 MG/DL. THE USER DID NOT SEEK MEDICAL TREATMENT AND STATED THAT NO ACTION WAS TAKEN TO RESOLVE THE EVENT. THE USER'S HCP WAS NOT AWARE OF THE EVENT, AND THE USER WAS ADVISED TO FOLLOW UP WITH THEIR HCP FOR FURTHER MEDICAL GUIDANCE.IN AN ASSOCIATED CASE OF SENSOR INACCURACY INCLUSIVE OF THE EVENT AND UNDER THIS CASE AN RMA WAS ISSUED FOR THE SENSOR. UPON RECEIPT, VISUAL INSPECTION REVEALED THAT A SMALL PORTION OF THE SENSOR HYDROGEL WAS MISSING, MOST LIKELY DUE TO EXCESSIVE FORCE APPLIED BY THE REMOVAL CLAMPS DURING THE EXTRACTION PROCEDURE, AND UNRELATED TO THE USER'S COMPLAINT. THIS DID NOT AFFECT THE FUNCTIONAL TESTING OF THE SENSOR, AS THE MAJORITY OF THE HYDROGEL REMAINED INTACT. IN-HOUSE TESTING SHOWED NO ISSUES WITH CHEMICAL PERFORMANCE. A REVIEW OF THE IN VIVO RAW DATA SHOWED OPTICAL INSTABILITY AROUND THE TIME OF THE REPORTED INACCURACIES. IN AN ASSOCIATED COMPLAINT (MFR #3009862700-2025-01295), DATED AUGUST 4, 2025, THE USER REPORTED AN INFECTION AT THE INSERTION SITE, WITH SYMPTOMS OF WARMTH AND REDNESS AROUND THE AREA, FOLLOWED BY WHITE PUS AND BLOOD. THIS EVENT MOST LIKELY CONTRIBUTED TO THE OBSERVED OPTICAL INSTABILITY AND THE RESULTING INACCURACIES. THE USER WAS PROVIDED WITH A REPLACEMENT SENSOR AS PART OF THE RESOLUTION. H3. DEVICE EVALUATED BY MANUFACTURER?YES. H6. TYPE OF INVESTIGATION UPDATED TO 4121,10. H6. INVESTIGATION FINDINGS UPDATED TO 3231. H6. INVESTIGATION CONCLUSIONS UPDATED TO 4310.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A HIGH GLUCOSE EVENT. THE FOLLOWING EXAMPLE SET WAS PROVIDED: ON (B)(6) 2025 AT 7:45 AM WHERE BG WAS 337 MG/DL AND SG WAS SG 68 MG/D. AFTER DMS REVIEW, WE CONFIRMED THE FOLLOWING INFORMATION AT THE TIME OF THE EVENT: ON (B)(6) 2025 AT 7:42 AM WHERE SG 68 MG/DL AND BG WAS 337 MG/DL. AFTER DMS REVIEW, WE CONFIRMED THAT THE USER DIDN'T RECEIVE A HIGH GLUCOSE ALERT AT THE TIME OF EVENT BECAUSE THE SG NEVER WENT ABOVE THE ALERT LEVEL.USER DIDN'T SEEK FOR MEDICAL TREATMENT. USER RESOLVED THE EVENT BY THEMSELF BUT DIDN'T TAKE ANY MEDICATION NOR ANYTHING TO SOLVE THEIR ISSUE. USER'S HCP ISN'T AWARE OF THE EVENT AND WAS ADVISED TO FOLLOW UP WITH THE HCP FOR FURTHER MEDICAL GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2887192 EVERSENSE SENSOR IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR SBA SENSEONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male