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

Model Number 101967-950

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

Patient Problems Abscess (1690); Fever (1858); Skin Infection (4544)

Event Date 01/13/2024

Event Type  Injury  

Manufacturer Narrative

This mdr is a result of retrospective review of complaints.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 customer went to the hcp who prescribed antibiotics and advised her to wait for 7 days to see if the infection subside.Patient also said in the meantime, she will not use the system.However, a review of the data management system (dms) was done after a week and it showed that the customer started using the system.This implies the infection subsided after taking antibiotics.No further investigation or actions were found necessary for this complaint.

Event Description

On january 15, 2024, senseonics was made aware of an incident where the patient had infection at the insertion site after her sensor exchange.Patient had symptoms such as redness, hotness and oozing around the wound.She also had fevers and shivers.The sensor was inserted on 09 january 2024 and the symptoms began on 13 january 2024.The patient visited hcp who gave antibiotics to treat infection.

• 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: 18764440
• MDR Text Key: 336050161
• Report Number: 3009862700-2024-00026
• Device Sequence Number: 1
• Product Code: QHJ
• 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: 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: 02/03/2024
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09243
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/06/2023
• 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