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

Model Number 101967-750

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

Patient Problem Discomfort (2330)

Event Date 07/30/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The insertion of new sensor was off label since it was inserted in a close proximity to the older sensor.This in turn created a linking issue for the user with the new sensor.Overall, the most likely root cause of this incident is due to the procedural error from the inserting physician.The newly inserted or the current sensor came out unfortunately while removing the old sensor due to their close proximity.

Event Description

Senseonics was made aware of an incident where newly inserted sensor came out along with the previous sensor due to the close proximity, while removing.This would require an additional procedure to get inserted with another sensor.

• Brand Name: EVERSESNE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 18991912
• MDR Text Key: 338886550
• Report Number: 3009862700-2024-00224
• 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: 03/27/2024

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: 02/14/2021
• Device Model Number: 101967-750
• Device Catalogue Number: FG-4400-10-302
• Device Lot Number: WP07957
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/14/2020
• 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