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

Model Number 101368-67A

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

Development of infection at the sensor insertion site is a known and anticipated potential adverse effect.There is no remedial action/corrective action/preventive action/field safety corrective action required in this case as the device is not defective.The infection was treated by medication at the healthcare facility.Based on the follow up received the sensor was not removed and the infection was healed and the patient is using the device.

Event Description

It was reported that one of the patients who was inserted with an eversense sensor developed an infection at the insertion site.The infection was characterized as the insertion site filled with pus.Patient received a dose of antibiotics from his wife which improved the condition.Patient has reported to seek medical attention.

• 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: 18270652
• MDR Text Key: 329775813
• Report Number: 3009862700-2023-00331
• 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: 12/05/2023

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: 12/25/2018
• Device Model Number: 101368-67A
• Device Catalogue Number: FG-4400-XX-302
• Device Lot Number: WP04174
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2019
• Initial Date FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other