MAUDE Adverse Event Report: SENSEONICS, INCORPORATED EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number 101368-67A

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

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

Event Date 06/19/2019

Event Type  Injury  

Event Description

Senseonics was recently made aware of a patient who was inserted with an eversense sensor developed a skin abscess at the sensor insertion site.The patient went to the hospital and required surgery for the abscess which caused removal of the sensor.The patient was on immunosuppressing medical treatment for a pre-existing condition and was hospitalized overnight after the abscess was drained.The patient was treated with antibiotics.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The healthcare professional at the hospital drained the abscess, removed the sensor and treated the patient with antibiotics.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS, INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS, INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 18747467
• MDR Text Key: 335872771
• Report Number: 3009862700-2024-00112
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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: 02/21/2024

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: 09/07/2019
• Device Model Number: 101368-67A
• Device Catalogue Number: FG-4400-XX-302
• Device Lot Number: WP04711
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2018
• 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