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 Pain (1994)

Event Date 12/25/2019

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where the patient experienced pain at the insertion site which then spread to whole arm and chest.Patient thought its a heart attack and went to the emergency room of the hospital.Doctor confirmed that it was not a heart attack and told the patient to go to diabetes center where it was decided to remove the sensor as the pain did not alleviate despite taking painkillers.

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.A review of the device's manufacturing documentation revealed that the sensor lot met sterilization requirements before release.The sensor was removed from the user due to pain.Pain at insertion site is a known and anticipated potential adverse effect.

• 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: 18654406
• MDR Text Key: 334698931
• Report Number: 3009862700-2024-00123
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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 Operator: Lay User/Patient
• Device Expiration Date: 02/23/2019
• Device Model Number: 101368-67A
• Device Lot Number: WP05508
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2019
• 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): Hospitalization