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 Pain (1994)

Event Date 03/20/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, senseonics was recently made aware of an incident where the patient reported pain around the insertion site to the upper part of her arm since the insertion of the eversense sensor.Multiple attempts were made to contact the patient to receive a status of the pain, but the patient was not responsive.

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.The device was not defective.The sterilization record for this lot of sensor was reviewed and the sensor was sterilized as per specifications.The potential to develop pain at the insertion site is a known and anticipated adverse effect of the system.There is no remedial action/corrective action/preventive action/field safety corrective action required in this case as the device is not defective.The potential to develop pain at the insertion site is a known and anticipated adverse effect of the system.Multiple attempts were made to contact the patient to receive a status of the pain, but the patient was non-responsive.

• 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: 18415807
• MDR Text Key: 331578874
• Report Number: 3009862700-2023-00364
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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: 12/28/2023

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: 06/12/2019
• Device Model Number: 101368-67A
• Device Catalogue Number: FG-4400-XX-302
• Device Lot Number: WP04220
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2018
• 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