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

Model Number 102096-81A

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

Patient Problems Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 12/27/2023

Event Type  Injury  

Manufacturer Narrative

This mdr is a result of retrospective review of complaints.The user reported a rash caused by the white adhesive patches with symptoms of redness.The white adhesive patches were not expired, no bandage or tegaderm were being used and the user does not use any kind of lotions or creams on the area.The user has a history of sensitive skin, mentioning that he is allergic to all kinds of adhesives.He requested the clear patches due to not having any issues with them and was granted a courtesy 90-day supply.The hcp is aware of the event and prescribed the user dexamethasone cream.No further investigation is required.

Event Description

On january 8, 2024, senseonics was made aware of an adverse event where the user experienced a rash from the white adhesive patches.

• 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: 18764457
• MDR Text Key: 336050677
• Report Number: 3009862700-2024-00065
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2023
• Device Model Number: 102096-81A
• Device Catalogue Number: FG-7200-00-301
• Device Lot Number: WP09137
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/16/2023
• 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
• Patient Age: 59 YR
• Patient Sex: Male