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

Model Number	102096-81A
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2025
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
On 12 april 2025, senseonics was made aware of an incident where user received an early sensor replacement alert resulting in an early sensor removal.To further evaluate the issue and to determine the root cause, a return material authorization (rma) was issued to bring the sensor back for investigation.
Additional Manufacturer Narrative
The sensor was tested in-house, and the review of investigation analysis revealed a degradation of the chemical performance, which confirmed the complaint.The system correctly disabled the sensor when it detected the performance degradation, and the system's self-test functions were working normally.The root cause of the performance degradation was due to oxidation of the chemical component of the sensor.The user was offered a sensor replacement as a resolution.B4.Date of this report 10 july 2025.G3.Date received by the manufacturer? 10 july 2025.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10 h6.Investigation findings updated to 3231 h6.Investigation conclusions updated to 4307.

• 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: 22006413
• Report Number: 3009862700-2025-00591
• Device Sequence Number: 12525498
• Product Code: QHJ
• UDI-Device Identifier: 00817491022950
• UDI-Public: 00817491022950
• 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): 07/10/2025

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: 02/22/2025
• Device Model Number: 102096-81A
• Device Catalogue Number: FG-7200-00-301
• Device Lot Number: WP09910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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: 63 YR
• Patient Sex: Male