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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Event or Problem Description
Senseonics was made aware of an incident where user reported that the transmitter melted after being connected to a charger while in europe.Based on the review of notes, photos, and dms data, the transmitter was found to be damaged and no longer usable.An rma was authorized for the return of the transmitter for further investigation.
Additional Manufacturer Narrative
The user reported that the transmitter melted while being charged in europe.The transmitter and usb cable were returned to senseonics for investigation.Visual inspection of the returned transmitter revealed melted housing in the region surrounding the micro-usb port.Despite the observed damage, the transmitter remained functionally operative.Evaluation of the transmitter battery indicated that battery capacity was within acceptable limits.Inspection of the returned usb cable identified physical damage and melting; the cable was unable to charge the transmitter.Review of user-supplied photos showed that a non-standard usb charge adapter was used to charge the transmitter, which likely resulted in voltage surges, increased power dissipation at the micro-usb interface.This condition likely contributed to localized heating and melting of the transmitter enclosure in the usb port.B4.Date of this report 03 jan 2026.G3.Date received by the manufacturer? 03 jan 2026.H3.Device evaluated by manufacturer? yes.H6.Medical device problem code updated to 1437.H6.Type of investigation updated to 10.H6.Investigation findings updated to 4248.H6.Investigation conclusions updated to 19.

• 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: 23472950
• Report Number: 3009862700-2025-01824
• Device Sequence Number: 13318960
• Product Code: SBA
• UDI-Device Identifier: 00817491024237
• UDI-Public: 00817491024237
• 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: 2024
• 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): 01/03/2026

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: 09/13/2025
• Device Model Number: 104208-600
• Device Catalogue Number: FG-4000-01-001
• Device Lot Number: 01E312S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2025
• Supplement Date Received by Manufacturer: 01/03/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 01/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 65 YR
• Patient Sex: Male