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

Model Number 101967-931

Device Problem Difficult to Remove (1528)

Patient Problem Discomfort (2330)

Event Date 02/05/2024

Event Type  Injury  

Event Description

On (b)(6) 2024, senseonics was made aware of an incident where physician was unable to remove the sensor on the first attempt made.

Manufacturer Narrative

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

Manufacturer Narrative

It was reported that the previous sensor of the user could not be removed.The sensor was palpable, and a transmitter was used to localize the sensor.Multiple attempts were made to get additional information about the removal status of the sensor.However, the user remained unresponsive.No further investigation was possible for this complaint.B4.Date of this report 25 april 2024.G3.Date received by the manufacturer? 25 april 2024.

• 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: 18867020
• MDR Text Key: 337232401
• Report Number: 3009862700-2024-00554
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/22/2023
• Device Model Number: 101967-931
• Device Catalogue Number: FG-4500-31-302
• Device Lot Number: WP09237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Other