MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number	103606-610
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, senseonics was made aware of an incident where user experienced sensor inaccuracy.No injury or medical intervention was reported.
Additional Manufacturer Narrative
The user reported discrepancies between bg and sg readings.Upon review of the sensor data available in the data management system (dms), indicated that the system was working within expectations and did not show any concerns about the health of the sensor.Overall, bg values meet the sg trends well.The observed differences were attributable to the expected lag between bg and sg inherent to the sensing technology.The user was advised to continue using the system and to enter calibrations when glucose trends are not changing rapidly.User agreed with the escalation response when it was shared.Data management system (dms) review confirmed the user was using the system with up-to-date information.This mdr is submitted retrospectively following an internal review.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 25494195
• Report Number: 3009862700-2026-02085
• Device Sequence Number: 21344659
• Product Code: SBA
• UDI-Device Identifier: 00817491024299
• UDI-Public: 00817491024299
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/02/2026
• Device Model Number: 103606-610
• Device Catalogue Number: FG-7501-00-301
• Device Lot Number: 01G034S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male