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

Model Number 101967-710

Device Problem Difficult to Remove (1528)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 04/29/2021

Event Type  Injury  

Event Description

On february 21, 2024, senseonics was made aware of an incident where previous sensor could not be removed during initial removal procedure on (b)(6) 2021.The sensor was inserted in (b)(6) 2020.The hcp at that time could not remove the sensor as it could not be localized.No further attempts were made until now since the user was under blood thinner treatment.A second attempt was made on (b)(6) 2024 and the sensor was successfully removed.

Manufacturer Narrative

Inability or difficulty to remove sensor during first attempt is a known and anticipated potential risk and eversense e3 user guide mentions about it under "risks and side effects".For this incident, the sensor removal was not possible during the first attempt because the sensor could not be localized.Furthermore, the user was on blood thinning medication (ass100 + brilique) and the hcp decided to not remove it at that time.A second attempt was made on (b)(6) 2024 and the sensor was successfully removed.This incident does not require any further investigation.

• 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: 18956130
• MDR Text Key: 338306209
• Report Number: 3009862700-2024-00093
• Device Sequence Number: 1
• Product Code: QHJ
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/18/2020
• Device Model Number: 101967-710
• Device Catalogue Number: FG-4400-10-302
• Device Lot Number: WP07731
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2019
• 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