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 11/20/2023

Event Type  Injury  

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".The information on why the sensor could not be removed during first attempt, was not provided.The sensor was surgically removed on (b)(6) 2023 and infection was found at insertion site.A separate case was created to document infection at insertion site.The vigilance report for infection as submitted separately (complaint: (b)(4) / bfarm case: (b)(4).Antibiotics was prescribed by the hcp to treat infection and the patient is currently doing fine.This incident does not require any further investigation.

Event Description

On march 7, 2024, senseonics was made aware of an incident where previous sensor could not be removed during initial removal procedure on (b)(6) 2023.The sensor was inserted on (b)(6) 2023.The sensor was successfully removed by a surgeon in the hospital outpatient department on (b)(6) 2023.

• 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: 19056161
• MDR Text Key: 339547936
• Report Number: 3009862700-2024-00605
• 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
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/12/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09042
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2022
• 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