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 Problem Unspecified Infection (1930)

Event Date 11/30/2019

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where the sensor was removed from the patient due to infection at the insertion site.Sensor was removed from the patient to treat the site of infection.It is also reported that a new sensor was inserted later and the patient is doing well.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The sensor was removed from the user due to pain and abscess.The sensor inaccuracy issue that the user was experiencing (b)(4) is likely to be due to the abscess.Pain and infection at insertion site are known and anticipated potential adverse effects.There is no remedial action/corrective action/preventive action/field safety corrective action required in this case as the product is not defective.

• 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: 18654515
• MDR Text Key: 334699622
• Report Number: 3009862700-2024-00124
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: NO
• 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: 02/06/2024

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 Expiration Date: 01/18/2020
• Device Model Number: 101368-67A
• Device Lot Number: WP05694
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2019
• 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