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

Model Number 101967-950

Device Problem Device Sensing Problem (2917)

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

Event Date 10/20/2023

Event Type  malfunction  

Event Description

Senseonics was made aware of an incident where the customer received several "sensor check" alerts since the insertion.The customer complained that she did not ever leave the initialization phase since the insertion on (b)(6) 2023.This incident and the system performance was reviewed via a review of data management system (dms) and it was determined that there was a performance deviation.Sensor was replaced and was requested back for further evaluation.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.(b)(6) (sensor check alert) was first presented to the customer on (b)(6) 2023, day 11 after insertion.There were four additional unique sensor check alerts also asserted on (b)(6) 2023, hence the sensor was replaced and returned for further investigation returned (b)(6) was tested in-house, and qc data revealed adequate chemical performance, but optical instability was also observed.The raw sensor in vivo data also showed a downward shift in signal and reference channel with increased optical instability.This is indicative of delamination of the photodiodes from the epoxy bonding in the sensor.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 18754859
• MDR Text Key: 336759144
• Report Number: 3009862700-2024-00532
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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
• Report Date: 02/21/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09143
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2022
• 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