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

Model Number	102812-81A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Senseonics was made aware of an incident where user reported a broken sensor during the removal procedure was reported on (b)(6) 2025.According to the health care provider (hcp), the sensor fractured into two pieces during removal.The sensor had been implanted in the left arm, and the clamp provided in the vygon removal kit was used during the procedure.The user was contacted but was unresponsive.All fragments of the sensor were successfully removed and retained for return, and a return material authorization (rma) was created for further investigation.The user is not currently using the system as the sensor had reached end of life.
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Additional Manufacturer Narrative
The territory manager reported that sensor broke during a removal appointment on (b)(6) 2025.The sensor was returned to senseonics for further investigation, and visual inspection confirmed that the sensor fractured into two pieces, with the fracture observed at the long-end region; all pieces were successfully extracted.Sensor fracture is typically associated with excessive force applied by removal clamps or grasping an extremity of the sensor.In some cases, tissue encapsulation at the insertion site may obstruct removal, which can lead the healthcare professional to apply increased force and increase the risk of sensor fracture.B4.Date of this report 20 jan 2026.G3.Date received by the manufacturer? 20 jan 2026.H3.Device evaluated by manufacturer?yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 4248.H6.Investigation conclusions updated to 4311.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR
• 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: 23953781
• Report Number: 3009862700-2026-00061
• Device Sequence Number: 9201593
• Product Code: QHJ
• UDI-Device Identifier: 00817491022974
• UDI-Public: 00817491022974
• 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: 2023
• 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): 01/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/03/2023
• Device Model Number: 102812-81A
• Device Catalogue Number: FG-7202-00-301
• Device Lot Number: WP09134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/04/2026
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2022
• 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 Sex: Unknown