MAUDE Adverse Event Report: Senseonics Inc. Eversense Sensor; Implantable Glucose Monitoring System

Model Number	103606-620
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On august 13th 2025, senseonics was made aware of an incident where user experienced sensor inaccuracy.No injury or medical intervention was reported.
Additional Manufacturer Narrative
This mdr is submitted retrospectively following an internal review and updated best practices in the reporting criteria.The user reported differences between sg and bg readings.Escalation analysis indicated that the system was working within expectations.The observed discrepancies were attributable to lag between the sg and bg inherent to sensing technology.Customer care advised the user to continue using the system and to reach out if they had any further concerns.

• Brand Name: Eversense Sensor
• Common Device Name: Implantable Glucose Monitoring System
• Manufacturer (Section D): Senseonics Inc.; 20451 senenca meadows parkway; germantown MD 20876 -700
• Manufacturer (Section G): Senseonics Inc.; 20451 senenca meadows parkway; germantown MD 20876 -700
• Manufacturer Contact: vallikannu somasundaram ; 20451 senenca meadows parkway; germantown, MD 20876--700
• MDR Report Key: 50114583
• Report Number: 3009862700-2026-02358
• Device Sequence Number: 17456106
• Product Code: SBA
• UDI-Device Identifier: 00817491024305
• UDI-Public: 00817491024305
• 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
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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: 03/03/2026
• Device Model Number: 103606-620
• Device Catalogue Number: FG-7502-00-301
• Device Lot Number: 01F133S
• 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: 08/13/2025
• Initial Report FDA Received Date: 08/03/2026
• Date Device Manufactured: 04/02/2025
• 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: 66 YR
• Patient Sex: Female