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

Model Number 102812-81A

Device Problem Failure to Sense (1559)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, senseonics was made aware of an incident where user received an early sensor replacement alert resulting in an early sensor removal.

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Manufacturer Narrative

The sensor replacement alert was first presented to the user on 21st of november 2023, day 121 after insertion.The sensor was tested in-house, and the review of investigation analysis revealed a loss of chemical performance.The in-vivo data confirms the complaint with diminished signal throughout the insertion period.The system correctly disabled the sensor when it detected the performance failure, and the system's self-test functions were working normally.The root cause of the performance failure was due to the sensor's hydrogel oxidation.As part of resolution, a return material authorization was issued for sensor replacement.No further resolution was necessary for this complaint.B4.Date of this report 26 april 2024 g3.Date received by the manufacturer? 12 feb 2024 h3.Device evaluated by manufacturer? yes h6.Type of investigation updated to 10 h6.Investigation findings updated to 3231 h6.Investigation conclusions updated to 4307.

• Brand Name: EVERSENSE SENSOR
• Type of Device: 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: 18406024
• MDR Text Key: 331670815
• Report Number: 3009862700-2023-01021
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022974
• UDI-Public: 817491022974
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 102812-81A
• Device Catalogue Number: FG-7202-00-301
• Device Lot Number: WP09237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male