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 Wound Dehiscence (1154); Discomfort (2330)

Event Date 01/10/2024

Event Type  Injury  

Manufacturer Narrative

This mdr is a result of retrospective review of complaints.The user was inserted with the sensor on the (b)(6) 2023.During the user's follow-up appointment with the inserting hcp, the hcp noticed the steri-strips had fallen off and the wound was open with the sensor visible outside the skin.The hcp removed the sensor, and the wound was cleaned.No infection was present and the hcp prescribed mupirocin ointment.No further investigation is required.

Event Description

On january 10, 2024, senseonics was made aware of an adverse event where territory manager called on behalf of the user to report an incident where the user's sensor had to be removed due to the steri-strips falling off and uncovering an open wound with the sensor sticking out.The wound was cleaned and closed by same inserting hcp.

• 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: 18764448
• MDR Text Key: 336050438
• Report Number: 3009862700-2024-00067
• 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: 01/05/2024
• Device Model Number: 102096-81A
• Device Catalogue Number: FG-7200-00-301
• Device Lot Number: WP09140
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/28/2023
• 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: 56 YR
• Patient Sex: Female