MAUDE Adverse Event Report: Senseonics Inc. Eversense Sensor; Eversense Continuous Glucose Monitor System

Model Number	103606-600
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, senseonics was made aware of an incident where user received a glucose suspend alert which resulted in an early sensor removal.
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

• Brand Name: Eversense Sensor
• Common Device Name: Eversense Continuous Glucose Monitor System
• Manufacturer (Section D): Senseonics Inc.; 20451 seneca meadows parkway; germantown 20876 -700
• Manufacturer (Section G): Senseonics Inc.; 20451 seneca meadows parkway; germantown 20876 -700
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876--700
• MDR Report Key: 50927137
• Report Number: 3009862700-2026-03370
• Device Sequence Number: 9509305
• Product Code: SBA
• UDI-Device Identifier: 00817491024282
• UDI-Public: 00817491024282
• 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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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 Model Number: 103606-600
• Device Catalogue Number: FG-7500-00-301
• Device Lot Number: 01G160S
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2026
• 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: 69 YR
• Patient Sex: Male