MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE TRANSMITTER; IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER

Model Number	104208-600
Medical Device Problem Codes	Overheating of Device (1437); Battery Problem (2885)
Health Effect - Clinical Codes	Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is currently performing investigation and the results will be provided in the supplemental report.
Event or Problem Description
Senseonics was made aware of an incident in which the user reported that the transmitter became extremely hot.A review of dms indicated that the user has not been using the system since (b)(6) 2025 due to this issue.An rma was authorized for the return of the transmitter for further investigation.
Additional Manufacturer Narrative
The user reported that the transmitter became hot while on their arm, with an associated complaint regarding a skin burn resulting in irritation and pain (mfr#3009862700-2025-01655).Investigation was performed on the returned transmitter, and it was determined that the transmitter's battery capacity was acceptable, and the device was operating within expectations.Visual inspection revealed no battery anomalies, no physical damage, and no evidence of overheating inside the transmitter.Log file analysis and in-house testing also showed no indication of transmitter overheating.The user later clarified that the irritation and swelling were not aligned with the transmitter's placement on the arm.Based on the available information, the user's reported issue was likely unrelated to the device.B4.Date of this report 22 nov 2025.D4.Additional device information updated.G3.Date received by the manufacturer? 22 nov 2025.H3.Device evaluated by manufacturer? yes.H6.Health effect - clinical code updated to 1757.H6.Health effect -impact code updated to 4613.H6.Medical device problem code updated to 1437.H6.Type of investigation updated to 10.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 67.

• Brand Name: EVERSENSE TRANSMITTER
• Common Device Name: IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER
• 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: 23129798
• Report Number: 3009862700-2025-01457
• Device Sequence Number: 7311216
• Product Code: SBA
• UDI-Device Identifier: 00817491024237
• UDI-Public: 817491024237
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P160048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/22/2025

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: 09/13/2025
• Device Model Number: 104208-600
• Device Catalogue Number: FG-4000-01-001
• Device Lot Number: 301842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2025
• Supplement Date Received by Manufacturer: 11/22/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 11/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 41 YR
• Patient Sex: Female