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

Model Number	104208-600
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
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 08 july 2025, senseonics was made aware of an incident where user reported an event where the cgm showed results that are different from glucometer measurements.No injury or medical intervention was reported.An rma was authorized for return of transmitter for further investigation.
Additional Manufacturer Narrative
On july 8, 2025, the user informed senseonics that the system was displaying results different from glucometer measurements.Based on the escalation analysis, a transmitter replacement was approved, and an rma was issued for the return of the transmitter for further investigation.Upon receipt, in-house testing of the returned transmitter showed no malfunction.A review of the in-vivo data revealed atypical temperature sensitivity, which likely contributed to the observed inaccuracies and noise in sensor glucose readings.The user was advised to move to a cooler environment when the issue arises and, during extended time outdoors in high temperatures, to wear a lightweight jacket or long-sleeve shirt to provide protection over the sensor and transmitter.Following transmitter replacement, the issue has not recurred, and no further inaccuracies have been reported.B4.Date of this report 06 oct 2025.G3.Date received by the manufacturer? 06 oct 2025.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10,4121.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR
• Manufacturer (Section D): SENSEONICS INC.; 20451 senenca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 senenca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 senenca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 22742375
• Report Number: 3009862700-2025-01178
• Device Sequence Number: 7282889
• 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: 2025
• 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): 10/06/2025

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: 12/04/2025
• Device Model Number: 104208-600
• Device Catalogue Number: FG-4000-01-001
• Device Lot Number: 02E353S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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: 44 YR
• Patient Sex: Male