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

Model Number 101967-950

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

Patient Problems Abscess (1690); Discomfort (2330); Skin Infection (4544)

Event Date 07/26/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.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 sensor was inserted on (b)(6) 2023.The customer first noticed symptoms (warmth, pus, and slight pain at the insertion site) on (b)(6) 2023 (day 67 of sensor life).The system asserted a sensor replacement alert and retired the sensor the next day, (b)(6) 2023.The customer scheduled an appointment for the same day to have the sensor removed and get a new sensor inserted.When the customer visited the hcp's office on (b)(6) 2023, the hcp examined the site and confirmed infection at the site of the retired sensor.The sensor was removed was inserted with another eversense e3 sensor.The customer is doing fine and does not have further issues.No further investigation was found necessary for this complaint.

Event Description

Senseonics was made aware of an incident where the patient's hcp observed and confirmed infection at the insertion site during the time of removal of the sensor, on (b)(6) 2023.The customer first noticed (experienced) the symptoms on (b)(6) 2023.The site of infection was hot and the patient had little pain and pus around the sensor.After the sensor was removed, the patient had no more pain and felt well.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 18117253
• MDR Text Key: 327879836
• Report Number: 3009862700-2023-00289
• 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: 11/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/23/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP08965
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2022
• 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