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 07/13/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On december 18, 2023, senseonics was made aware of an incident where the user's previous sensor could not be removed during the initial removal procedure on (b)(6) 2023 and during another removal attempt on (b)(6) 2023.The sensor could not be removed because it could not be palpated and unable to locate using either eversense transmitter or an ultrasound.A third removal attempt will happen tentatively on (b)(6) 2024 and x-ray will be used this time.

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 sensor removal attempt was made on (b)(6) 2023 and second attempt was made on (b)(6) 2023, but was unsuccessful because sensor could not be detected either with transmitter or ultrasound.Sensor was unable to be palpated before incision.A third attempt was made on (b)(6) 2024 and this time x-ray was used to locate the sensor.Removal was successful.B4.Date of this report 25 april 2024.D6b.Explanted date updated to (b)(6) 2024.G3.Date received by the manufacturer? 02 feb 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: 18531974
• MDR Text Key: 333086065
• Report Number: 3009862700-2024-00012
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023308
• UDI-Public: 817491023308
• 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,Followup
• Report Date: 04/25/2024

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: 04/14/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP08959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2022
• 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