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

Catalog Number FG-6403-01-300

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

Patient Problem Skin Erosion (2075)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The patient decided to stop using the system due to skin irration from the adhesive patch.The sensor was removed on (b)(6) 2019.No further medical intervention was required.

Event Description

Senseonics was made aware of an incident where the patient experienced severe skin irritation at the site where the eversense adhesive patch was located.As a result of the skin irritation, the patient suspended use of the eversense cgm system.

• Brand Name: EVERSENSE ADHESIVE PATCH
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.
• 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: 18489571
• MDR Text Key: 332601337
• Report Number: 3009862700-2023-00388
• 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: 01/10/2024

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 Catalogue Number: FG-6403-01-300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male