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 Problem Skin Infection (4544)

Event Date 02/11/2023

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.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.Sensor was removed from the patient's arm due to the symptoms which likely led to the deviation in the sensor performance (sensor inaccuracies).The wound was disinfected and a strip was placed in the wound to clean it from the inside.No medication was prescribed and no separate wound treatment was performed.The patient will be re-inserted with a new sensor to continue using eversense system.No further investigation was found necessary this complaint.

Event Description

Senseonics was made aware of an incident where patient reported infection at the insertion site.There was inflammation at the insertion site and the insertion scar had opened and pus was coming out.Patient had earlier reported sensor inaccuracies issue which was escalated to next level support who approved a sensor replacement due to deviation in the sensor performance, likely due to inflammation/infection at the insertion site.The sensor was removed on (b)(6) 2023 and the wound was disinfected and a strip was placed in the wound to clean it from the inside.The patient would be re-inserted with a new sensor once the would is healed.

• 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: 18117219
• MDR Text Key: 327880224
• Report Number: 3009862700-2023-00249
• 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: 11/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/16/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP08962
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2022
• 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