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

Model Number 101967-950

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The inserting hcp confirmed that the sensor had remained inside the sensor holder of the insertion tool and it did not get implanted during the insertion procedure that took place on (b)(6) 2023.This was discovered after the patient was unable to link the sensor to the transmitter despite trying several times.The hcp admitted that it was the error from their end to not check if the sensor got implanted or it remained inside the holder.The hcp normally checks that, but forgot in this case.The hcp, however, confirmed that there was no issue with the insertion tool.Since there was no issue with the device or the insertion tool, no further investigation was found necessary for this complaint.As resolution, a new sensor will be inserted to the patient.

Event Description

Senseonics was made aware of an incident where patient had issues linking the sensor with the transmitter.The patient did not get any signal with the sensor.Upon consulting the hcp, it was found that the sensor was still in sensor holder.The hcp confirmed that there was no issue with the insertion tool, but they did not check after the insertion procedure if the sensor remained inside the holder.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows pkwy; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows pkwy; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows pkwy; germantown, MD 20876-7005
• MDR Report Key: 18117318
• MDR Text Key: 327880167
• Report Number: 3009862700-2023-00300
• 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: 11/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2023
• 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
• Date Manufacturer Received: 11/03/2023
• 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