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	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted retrospectively as part of internal review.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 reported inaccuracy in sensor readings.No injury or medical intervention was reported.
Additional Manufacturer Narrative
On 20th dec 2024, the user informed senseonics that the cgm showed results that were different from glucometer measurements.A review of the dms data showed transient signal and reference channel instability starting (b)(6) which coincided with the inaccuracies observed by the user.The system recovered from this instability around (b)(6) and showed better agreement between sensor glucose and blood glucose onwards.The instability observed is potentially due to poor recovery from impacts to the insertion site affecting the in vivo state of the hydrogel, such as the hydrogel interface being interfered with coagulated blood.Case notes do not mention any impact to the insertion site.However, we do not expect every minor to major impact to the insertion site to be memorable so confirmation from the user is not a requirement for concluding this type of behavior is potentially from an impact to the insertion site.This most likely contributed to the observed sensor inaccuracies.A transmitter replacement was approved for this user for the purposes of upgrading their firmware and is not related to the reported event.No further investigation into the transmitter is required.B4.Date of this report 19 march 2025.G3.Date received by the manufacturer? 19 march 2025.H3.Device evaluated by manufacturer? yes.H6.Component code updated to 510.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.

• 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: 21366786
• Report Number: 3009862700-2025-00172
• Device Sequence Number: 8452316
• 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
• 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): 03/19/2025

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: 08/11/2025
• Device Model Number: 104208-600
• Device Catalogue Number: FG-4000-01-001
• Device Lot Number: 02E284S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2024
• 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: 60 YR
• Patient Sex: Male