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

Model Number 101967-931

Device Problem Device Sensing Problem (2917)

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

Event Date 12/21/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On december 25th 2023, senseonics was made aware of an incident where customer complains of sensor check alerts resulting in an early sensor removal.

Manufacturer Narrative

Ec34 (sensor check alert) was first presented to the customer on 18 december 2023, day 63 after insertion.There were multiple sensor check alerts that were also asserted afterward, and a transmitter diagnostic upload showed that the sensor check alert was triggered on (b)(6) due to sensor delamination.Hence the sensor was replaced and returned for further investigation.Returned sensor 415018 was tested in-house, and qc data revealed optical instability.This is indicative of delamination of the photodiodes from the epoxy bonding in the sensor.As part of resolution, the rma was authorized to offer the user a sensor replacement.B4.Date of this report updated to 18 march 2024 d9 device available for evaluation? yes, device received on 31 jan 2024 h3.Device evaluated by manufacturer?yes h6.Type of investigation updated to 10.H6.Investigation findings updated to 4210.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: 18577208
• MDR Text Key: 334620206
• Report Number: 3009862700-2024-00001
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023681
• UDI-Public: 817491023681
• Combination Product (y/n): Y
• Reporter Country Code: IS
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/03/2024
• Device Model Number: 101967-931
• Device Catalogue Number: FG-4500-31-302
• Device Lot Number: WP09511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• 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