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

Model Number 101967-710

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

Patient Problem Unspecified Infection (1930)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.A review of the device's manufacturing records revealed that the sensor lot met all requirements including sterilization requirements for release.Hence, there was no malfunction with the device.The actual root cause of the incident, however, could not be determined.The probable root cause could be sensor placement not being ideal and too near to the epidermis and/or insertion site not completely healed.This could have possibly caused sensor coming out from the insertion pocket due to pus formation.Patient visited doctor who removed the sensor from the patient's arm and removed pus from the pocket.

Event Description

Senseonics was made aware of an instance where patient noticed that sensor was coming out of the skin.Patient visited doctor who removed the sensor.The sensor popped out of the tissue and it was a lot of pus out- and inside the tissue/pocket.The infection was only local.

• 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: 18961607
• MDR Text Key: 338384638
• Report Number: 3009862700-2024-00158
• 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: 03/22/2024

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: 09/12/2020
• Device Model Number: 101967-710
• Device Catalogue Number: FG-4400-10-302
• Device Lot Number: WP07531
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2020
• Initial Date FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2019
• 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