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

Model Number 101967-750

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

Patient Problems Inflammation (1932); Pain (1994); Discomfort (2330); Swelling/ Edema (4577)

Event Date 10/23/2019

Event Type  Injury  

Event Description

On october 25, 2021, senseonics was made aware of an incident where patient complained of inflammation at insertion site.The site is warm, swollen, the patient has a "ball" feeling under the skin, there is no exudate, but there is a thickening with fluid and blood.He was initially prescribed the drug ibuprofen to relieve the pain and fight the inflammation at the sensor site.The patient states that he felt a growing sensation gradually from the time the sensor was implanted, but from (b)(6) 2021, pain, swelling and a "ball" of fluid under the skin appeared.The doctor confirmed severe inflammation and decided to remove the sensor.The patient also wanted the sensor removed due to severe discomfort in his arm.

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.Based on the review of the manufacturing records, it can be concluded that there was no malfunction with the device.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 visited the doctor who confirmed severe inflammation and decided to remove the sensor.Patient also wanted to have the sensor removed because of discomfort.However, patient mentioned that he would like to continue using the system and would purchase a new sensor.

• 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: 18435841
• MDR Text Key: 331865645
• Report Number: 3009862700-2023-00663
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: PL
• 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: 01/03/2024

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: 03/08/2022
• Device Model Number: 101967-750
• Device Catalogue Number: FG-4400-50-302
• Device Lot Number: WP08438
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2021
• 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