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

Model Number 101967-950

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

Patient Problems Rash (2033); Anaphylactoid (2218); Skin Inflammation/ Irritation (4545)

Event Date 10/31/2023

Event Type  Injury  

Manufacturer Narrative

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.Patient reported that they get allergies every time a new sensor gets inserted, happening since the first insertion in 2019.The current sensor was patient's 10th sensor.The hcp told patient that it could be either due to lidocaine or insertion tools, sensor or adhesives (tegaderm and steri-strips).The hcp prescribed antihistamine and cortisone cream for prevention.The patient is still using the system with up to date glucose information.The patient was recommended to contact hcp for any medical assistance.This incident does not require any further investigation.

Event Description

Senseonics was made aware of an incident where patient reported allergic reaction every time a new sensor gets inserted, happening since 2019.The most recent sensor was inserted on (b)(6) 2023.The patient reported that they get allergic to everything, but nothing specific information was provided.The hcp said it could be related to lidocaine, tools, sensor or adhesives (tegaderm and steri-strips).Symptoms include redness and rash that spreads from her arm to her throat and disappears after three days.The hcp prescribed antihistamine tablets and cortisone cream for prevention.

• 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: 18361379
• MDR Text Key: 330930945
• Report Number: 3009862700-2023-00830
• Device Sequence Number: 1
• Product Code: QHJ
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09149
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/10/2023
• 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