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

Device Problem Installation-Related Problem (2965)

Patient Problem Discomfort (2330)

Event Date 10/18/2022

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The incident occurred due to procedural error.The hcp mentioned that was an oversight not to implant the sensor.The sensor wasn't inserted because the insertion tools weren't handled correctly, the sensor wasn't taken out of the cap and the empty cutlery was used and pushed into the patient's skin.The sensor was still inside the cap when it was disposed and it couldn't be used anymore.Another sensor was inserted successfully on (b)(6) 2022.The patient is doing fine and the hcp did not have to give the patient any medication.No further investigation is necessary for this complaint.

Event Description

Senseonics was made aware of an incident where it was discovered that sensor was never inserted after patient experienced issues linking sensor to the transmitter.Hcp reported that the sensor wasn't inserted because the insertion tools weren't handled correctly, the sensor wasn't taken out of the cap and the empty cutlery was used and pushed into the patient's skin.As per notes, sensor was still inside the cap when it was disposed, sensor couldn't be used anymore.New insertion took place today (b)(6) 2022 and it was confirmed in dms that the sensor sn (b)(6) has now been linked and the user has entered warm up phase.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown
• 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: 18117205
• MDR Text Key: 327879852
• Report Number: 3009862700-2023-00237
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: No
• 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