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

Model Number 101967-931

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

Patient Problems Pain (1994); Discomfort (2330); Skin Inflammation/ Irritation (4545)

Event Date 12/14/2023

Event Type  Injury  

Manufacturer Narrative

This mdr is a result of retrospective review of complaints.A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.The sensor is inserted by making a small incision and placing it under skin and potential for developing skin irritation/swelling/pain/inflammation/infection around the insertion site is a known anticipated adverse event.The patient visited the hcp for pain at the removal site.Although there was no confirmed infection, antibiotics were prescribed by the hcp for prevention of any possible infection.According to the case notes, the patient is doing better and is currently using the system with up-to-date information.No further investigation was necessary for this complaint.

Event Description

On december 18, 2023, senseonics was made aware of an adverse event where the user experienced pain at the sensor removal site.

• 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: 18619972
• MDR Text Key: 334257354
• Report Number: 3009862700-2024-00033
• 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
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/24/2023
• Device Model Number: 101967-931
• Device Catalogue Number: FG-4500-31-302
• Device Lot Number: WP09143
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other