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

Model Number 101368-67A

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

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

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Patient reported that he doesn't have a history of sensitive skin.However, potential for developing skin irritation due to adhesive patch is a known anticipated adverse event.Furthermore, patient stopped using white adhesive patches and started using clear adhesive patches.No further investigation was found necessary for this complaint.

Event Description

Sensenoics was made aware of an incident where the patient experienced light itching that turned to redness and light inflammation.Patient reported that he was using white adhesive patches before and would start using clear adhesive patches in future.

• 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: 18423339
• MDR Text Key: 331769342
• Report Number: 3009862700-2023-00420
• 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 Expiration Date: 12/06/2019
• Device Model Number: 101368-67A
• Device Lot Number: WP05225
• 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: 11/29/2018
• 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