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

Model Number 101967-750

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Undesired Nerve Stimulation (1980); Discomfort (2330)

Event Date 10/15/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.There was no performance allegation with the sensor.The sensor is inserted by making a small incision and placing it under skin.Senseonics' chief medical officer explains that the sensor moves very minimally after insertion but remains within millimeters of where it was placed.Though sometimes user feels like the sensor is moving, it does not compromise the functionality of the sensor as long as the sensor is able to palpate the transmitter placement is proper.Tingling sensation occurs when the very small cutaneous nerves are cut (during insertion) and they start to heal.It's not from a big nerve or anything and usually feels tingling when you are touching it.Patient mentioned that the current sensor was his fourth one in the left arm.He was advised to always switch his arm after the two sensors in one arm.User was also advised to contact their hcp for more medical advise or treatment options.Since patient felt uncomfortable and annoyance, the distributor decided to offer the user a goodwill sensor replacement so that user can continue using eversense xl cgm system.

Event Description

Senseonics was made aware of an incident where patient reported tingling sensation in the arm.Patient believes that the sensor has migrated after insertion.He has the feeling that the sensor presses on a nerve from time to time and the place where the sensor is inserted tingles.This tingling sensation then travels down the arm through.Patient does not have any pain or any other symptoms.

• 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: 18998480
• MDR Text Key: 338884061
• Report Number: 3009862700-2024-00273
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491023360
• UDI-Public: 817491023360
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2022
• Device Model Number: 101967-750
• Device Catalogue Number: FG-4400-50-302
• Device Lot Number: WP08303
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2021
• 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