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

Model Number	104208-600
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
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
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Additional Manufacturer Narrative
On 19th jan 2025, the user informed senseonics that the cgm showed results that were different from glucometer measurements.A review of the system's overall performance showed occasional sg/bg difference that could be attributed to the lag between bg and sg inherent to the sensing technology.The in-vivosensor data did not reveal any anomalies.The user was helped with an fw upgrade on their transmitter (sn (b)(6)), and the system was monitored for few days.The system was re-initialized with calibration history cleared as part of the upgrade.Additional monitoring post upgrade indicated that the bg values fit sg trends well, with occasional differences due to calibrations entered during periods of rapid glucose change.On 22-jan-2026 at 8:13 am, the user independently decided to start using a spare transmitter in their possession (sn (b)(6)).The transmitter firmware was upgraded on 23-jan-2026 at 11:27 am, which resulted in system re-initialization again.Based on additional review, the calibrations entered after initial feedback was provided and following the transmitter change were all within expected system performance.The user was advised to continue using the system.During a follow-up call, the user requested evaluation of the original transmitter, as the issue appeared resolved after switching transmitters.A return-only rma was issued for transmitter sn (b)(6).Evaluation of the returned transmitter did not identify any malfunction.The observed improvement in accuracy was likely attributable to system re-initialization and correction of potential calibration misalignment.A review of 2 weeks' worth data (jan 27th to feb 10th 2026) following case closure indicated that the user's system continued to perform within expected parameters.

• 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: 24384760
• Report Number: 3009862700-2026-00323
• Device Sequence Number: 10185366
• 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): 04/16/2026

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: 05/15/2026
• Device Model Number: 104208-600
• Device Catalogue Number: FG-4000-01-001
• Device Lot Number: 01F178S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2025
• 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 Sex: Unknown