MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number	102812-81A
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is currently performing an investigation and will provide the results with the supplemental report.
Event or Problem Description
On november 4, 2024, senseonics was made aware of an incident where user received an early sensor replacement alert resulting in an early sensor removal.
Additional Manufacturer Narrative
The sensor replacement alert was first presented to the user on (b)(6) 2024, day 21 after insertion.The sensor was tested in-house, but the failure mode could not be reproduced during the return product analysis testing.This may occur in some instances where the failure mode that presents itself is in the body is not reproduced in the lab.The review of the sensor data in dms showed the sensor was taking longer than usual to stabilize after insertion, which eventually triggered the sensor replacement alert.The potential root cause for this slow recovery post-insertion is coagulated blood from the insertion process interfering with the interface of the hydrogel.As part of resolution, the rma was authorized for sensor replacement.B4.Date of this report 31 january 2025.G3.Date received by the manufacturer? 31 january 2025.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 114.H6.Investigation conclusions updated to 4315.

• Brand Name: EVERSENSE SENSOR
• Common Device Name: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• 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: 20845999
• Report Number: 3009862700-2024-01090
• Device Sequence Number: 20871080
• Product Code: QHJ
• UDI-Device Identifier: 00817491022974
• UDI-Public: 00817491022974
• 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): 01/31/2025

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: 05/02/2025
• Device Model Number: 102812-81A
• Device Catalogue Number: FG-7202-00-301
• Device Lot Number: WP09978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/31/2025
• 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: 68 YR
• Patient Sex: Female