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

Model Number 101368-67A

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

Patient Problems Erythema (1840); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Discomfort (2330)

Event Date 05/24/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The risks identified for the eversense¿ cgm system are common to all cgm systems even though a minor surgical procedure is required for insertion and removal of the sensor.These include local infection, pain or discomfort, inflammation, bleeding at the insertion or removal site, bruising, itching, scarring or skin discoloration, hematoma, erythema, adhesive tape irritation and sensor fracture.There is no remedial action/corrective action/preventive action/field safety corrective action required in this case as the device is not defective.The sterilization record for this lot of sensor was reviewed and the sensor was sterilized as per specifications.

Event Description

Senseonics was recently made aware of an incident where one of the patients who was inserted with an eversense sensor reported the incision site started to turn red and there was slight pain when touched a week after the insertion and stated the incision is now healed.The patient reported that his physician did not prescribe any cream or antibiotics.The eversense sensor was not removed.The patient could not be reached after multiple attempts to determine if he developed an infection at the insertion site.

• Brand Name: EVERSENSE SENSOR
• Type of Device: IMPLANTABLE GLUCOSE MONITORING SYSTEM SENSOR
• 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: 18455962
• MDR Text Key: 332206994
• Report Number: 3009862700-2023-00382
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/18/2019
• Device Model Number: 101368-67A
• Device Catalogue Number: FG-4400-XX-302
• Device Lot Number: WP04608
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2018
• 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