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

Model Number 101967-931

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

Patient Problem Unspecified Infection (1930)

Event Date 01/24/2024

Event Type  Injury  

Manufacturer Narrative

A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.The sensor is inserted by making a small incision and placing it under skin and potential for developing skin irritation/swelling/pain/ inflammation/infection around the insertion site is a known anticipated adverse event.The user went to a scheduled sensor removal/insertion appointment where the hcp noticed an affection at the insertion site of the old sensor.The hcp decided not to remove the sensor and to wait three weeks before attempting the removal.The new sensor was inserted into the opposite arm.No antibiotics were prescribed by the hcp.No further investigation for found necessary.

Event Description

On (b)(6) 2024, senseonics was made aware of an adverse event where hcp noticed an infection at the insertion site during the removal procedure.The hcp decided not remove the sensor until the infection was healed and to insert the new sensor in the opposite arm.

• 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: 18773792
• MDR Text Key: 336178261
• Report Number: 3009862700-2024-00036
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: IS
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/03/2024
• Device Model Number: 101967-931
• Device Catalogue Number: FG-4500-31-302
• Device Lot Number: WP09511
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/22/2023
• 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