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 Problem Skin Discoloration (2074)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.Potential for development of skin discoloration at the sensor insertion site is a known and anticipated potential adverse effect.The manufacturer reviewed the certificate of conformance for the lot associated with this sensor and was concluded that the lot met the sterilization requirements.The risks identified for the eversense¿ cgm system are common to all cgm systems even though a minor surgical procedure is required for insertion and removal of the sensor.These include local infection, pain or discomfort, inflammation, bleeding at the insertion or removal site, bruising, itching, scarring or skin discoloration, hematoma, erythema, adhesive tape irritation and sensor fracture.Potential for development of skin discoloration at the sensor insertion site is a known and anticipated potential adverse effect.Sensor was removed from the patient to resolve the issue.Furthermore, the manufacturer reviewed the certificate of conformance for the lot associated with this sensor and was concluded that the lot met the sterilization requirements.No remedial action/corrective action/preventive action/field safety corrective action is required.

Event Description

Senseonics was made aware of an instance where the patient experienced skin discoloration of the skin in the area of the insertion.She went to the doctor and the sensor was removed.

• 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: 18278844
• MDR Text Key: 329887276
• Report Number: 3009862700-2023-00411
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 12/06/2023

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: 07/25/2019
• Device Model Number: 101368-67A
• Device Lot Number: WP04600
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2020
• Initial Date FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other