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

Model Number	102096-81A
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Fatigue (1849); Hyperglycemia (1905); Nausea (1970)
Date of Event	11/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Senseonics was made aware of an incident where user experienced hyperglycemic episode.User experienced nausea and fatigue.
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Additional Manufacturer Narrative
User reported a hyperglycemia event which happened on 18-nov-2024.The user experienced symptoms such as nausea and fatigue.Multiple attempts were made to contact the user to collect additional information, but no response was received.Thus, no confirmation or further investigation of the complaint was possible.B4.Date of this report 29 sept 2025.G3.Date received by the manufacturer? 29 sept 2025.H6.Type of investigation updated to 4119.H6.Investigation findings updated to 3221.H6.Investigation conclusions updated to 67.

• 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: 22683778
• Report Number: 3009862700-2025-01251
• Device Sequence Number: 18509798
• 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): 09/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/02/2025
• Device Model Number: 102096-81A
• Device Catalogue Number: FG-7200-00-301
• Device Lot Number: 01E261S
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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: 58 YR
• Patient Sex: Unknown