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	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 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.
Additional Manufacturer Narrative
This report is being submitted retrospectively as part of internal review.The user reported a complaint regarding inaccurate sensor readings.The user was educated on expected behavior during the early wear period and lag.The user was also advised to avoid calibrating during periods of rapid glucose change.Subsequent monitoring of system performance indicated that the system was operating within expectations, with occasional discrepancies attributable to lag or calibrations entered during rapid glucose fluctuations.The user was advised to continue using the system and to calibrate as prompted.Escalation information was provided to the user, who acknowledged and understood the guidance.No further action was required.

• 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: 22018522
• Report Number: 3009862700-2025-00725
• Device Sequence Number: 8804887
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2025

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: 12/24/2025
• Device Model Number: 104208-600
• Device Catalogue Number: FG-4000-01-001
• Device Lot Number: 02F007S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/25/2024
• 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: 63 YR
• Patient Sex: Male