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

Device Problem Difficult to Remove (1528)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 12/20/2023

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 21, 2023, senseonics was made aware of an incident where the previous sensor could not be removed during removal procedure on (b)(6) 2023.The hcp could not grab the sensor and could not locate it via ultrasound.Patient is feeling well.The next removal attempt will be made during next sensor exchange.

Manufacturer Narrative

Initially it was thought that the sensor could not be grabbed as it could not be located via ultrasound investigation.However during a transmitter placement test, no signal was detected and it was determined that the sensor never got inserted and probably got stuck inside the insertion tool.The hcp did not check the sensor holder to see if the sensor deployed during insertion procedure.An additional training will be provided to the hcp's office that performed insertion.As per the information that was received by senseonics, the patient is doing well and was not upset with the hcp about the procedural error.No further investigation was found necessary for this complaint.B4.Date of this report 25 april 2024.G3.Date received by the manufacturer? 04 april 2024.H3.Device evaluated by manufacturer? yes.

• 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: 18540640
• MDR Text Key: 333194343
• Report Number: 3009862700-2024-00003
• 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,Followup
• Report Date: 04/24/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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