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

Model Number 101368-67A

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

Patient Problem Abscess (1690)

Event Date 07/25/2019

Event Type  Injury  

Event Description

On august 2, 2019 senseonics became aware of an incident where a patient's scar from the insertion of a sensor began to swell and suppurate, at which time the patient pressed the pus out of the wound and the sensor slipped out.The customer let the wound heal after applying disinfectant.The patient did not contact their doctor and no antibiotics were taken.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The patient is suspected to have developed an insertion site infection.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.The patient did not contact their doctor and was not prescribed antibiotics.The patient applied disinfectant and reported that the wound healed.The sterilization record for this lot of sensors was reviewed and the sensor was sterilized as per specifications.

• 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: 18571119
• MDR Text Key: 333606107
• Report Number: 3009862700-2024-00117
• Device Sequence Number: 1
• Product Code: QCD
• 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: 01/24/2024

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: 08/30/2019
• Device Model Number: 101368-67A
• Device Catalogue Number: FG-4400-XX-302
• Device Lot Number: WP04634
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2019
• Initial Date FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/30/2018
• 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