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

Model Number 101368-67A

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)

Event Date 09/09/2019

Event Type  Injury  

Event Description

On december 19, 2019, senseonics was made aware of an instance where the patient developed an skin irritation at the insertion site.The patient is not using the system now because of the skin irritation.The doctor also confirmed that it is an allergic reaction and recommended the user to stop using the system.

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.A review of the device's manufacturing documentation revealed that the sensor lot met sterilization requirements before release.The sensor was removed on (b)(6) 2020.The doctor confirmed that it is an allergic reaction and recommended to stop using the system.The potential for infection post insertion is a known anticipated adverse event of eversense xl continuous glucose monitoring (cgm) device.

• 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: 19007932
• MDR Text Key: 338980995
• Report Number: 3009862700-2024-00120
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/26/2019
• Device Model Number: 101368-67A
• Device Lot Number: WP05020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2018
• 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