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

Model Number 01368-67A

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

Patient Problems Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 11/30/2019

Event Type  Injury  

Event Description

Senseonics was made aware of an instance where the patient developed skin irritation, itching and redness at the insertion site because of clear adhesive patch provided to the patient.Patient visited physician and received an ointment to put on.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.A review of the device's manufacturing records indicated that the sensor lot met all specifications for release and was sterilized as per specifications.Potential for developing skin irritation due to adhesive patch is a known anticipated adverse event.Furthermore, white adhesive patches were sent to the customer to see if those will work good for the patient.Follow up attempts were made to get additional information about the incident but no responses were received.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 18423340
• MDR Text Key: 331769406
• Report Number: 3009862700-2023-00419
• Device Sequence Number: 1
• Product Code: QCD
• 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: 01/01/2024

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: 02/14/2020
• Device Model Number: 01368-67A
• Device Lot Number: WP05648
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2020
• Initial Date FDA Received: 01/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/12/2019
• 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