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

Model Number 101967-950

Device Problem Difficult to Remove (1528)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 02/09/2024

Event Type  Injury  

Manufacturer Narrative

The manufacturer is currently waiting for information regarding next sensor removal attempt.The additional information will be provided in the supplemental report.

Event Description

On february 12, 2024, senseonics was made aware of an incident where previous sensor could not be removed during removal procedure on (b)(6) 2024.The sensor was inserted on (b)(6) 2023.The hcp was not able to grip the sensor.Sensor was palpable and an ultrasound and magnet were used to localize the sensor.The patient felt pain at the time of removal attempt.Another attempt is tentatively scheduled for 05- april -2024.

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 first removal attempt was made on (b)(6) 2024 where the hcp was not able to grip the sensor.Sensor was palpable and an ultrasound and magnet were used to localize the sensor.Another attempt was made was on (b)(6) 2024 and sensor was successfully removed.As of today, the customer is using the system with a new sensor (sn (b)(6)) and receiving up to date glucose information.This incident does not require any further investigation.B4.Date of this report (b)(6) 2024.D6b.Explanted date updated to (b)(6) 2024.G3.Date received by the manufacturer? (b)(6) 2024.

• 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: 18900012
• MDR Text Key: 337617570
• Report Number: 3009862700-2024-00560
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023308
• UDI-Public: 817491023308
• 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,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/24/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2022
• 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