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

Model Number 101967-750

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

Patient Problems Skin Infection (4544); Skin Inflammation/ Irritation (4545)

Event Date 01/03/2022

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where patient developed infection at insertion site.At the beginning of week of (b)(6) , patient noticed that the area became harder than usual, but she did not notice any signs of redness or heat.This was treated with anti-inflammatory medication (ibuprofen) and she noticed improvement.Later she noticed that the area itched abnormally during the night.Then on (b)(6) 2022, the user noticed after removing the transmitter the area began to ooze.The incision site was open.Her physician recommended to stop wearing the transmitter.She went to see her doctor on (b)(6) 2022 and the doctor recommended to remove the sensor.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Senseonics was made aware of an incident where patient developed infection at insertion site.At the beginning of week of (b)(6) , patient noticed that the area became harder than usual, but she did not notice any signs of redness or heat.This was treated with anti-inflammatory medication (ibuprofen) and she noticed improvement.Later she noticed that the area itched abnormally during the night.Then on (b)(6) 2022, the user noticed after removing the transmitter the area began to ooze.The incision site was open.Her physician recommended to stop wearing the transmitter.She went to see her doctor on (b)(6) 2022 and the doctor recommended to remove the sensor.

• Brand Name: EVERSENSE SENSOR
• Type of Device: IMPLANTABLE GLUCOSE MONITORING SYSTEM, SENSOR
• 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: 19009336
• MDR Text Key: 338981049
• Report Number: 3009862700-2024-00316
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491023360
• UDI-Public: 817491023360
• Combination Product (y/n): Y
• Reporter Country Code: SP
• 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: 03/31/2024

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: 01/14/2022
• Initial Date FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: No
• 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