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

Model Number 101967-950

Device Problems Installation-Related Problem (2965); No Apparent Adverse Event (3189)

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

Event Date 11/22/2023

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where the patient had to go through another insertion procedure because during the initial insertion procedure, the sensor got stuck in the insertion tool.The initial insertion procedure was scheduled on (b)(6) 2023 and initially it was thought that sensor was inserted.But then it was determined that the sensor got stuck in the insertion tool itself.The patient had to go through another insertion procedure.No clinical symptoms were reported by the user.

Manufacturer Narrative

Manufacturer has requested the return of insertion tool.Once the device is returned, manufacturer will perform addition investigation and the results will be submitted in a supplemental report.

Manufacturer Narrative

According to the information that was received by senseonics, the sensor was found to be still inside the insertion tool and they had to break it because there was no way to get the sensor out.A return material authorization (rma) was issued for the insertion tool to return for further investigation and to determine the root cause.However, the insertion tool was returned dismantled in pieces.As a result, no further investigation was possible.The root cause could not be determined as the issue could not be replicated due to dismantled pieces.B4.Date of this report 26 april 2024.G3.Date received by the manufacturer? 11 jan 2024.H3.Device evaluated by manufacturer? no h6.Type of investigation updated to 4113.H6.Investigation findings updated to 3221.H6.Investigation conclusions updated to 67,4315.

• 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: 18406174
• MDR Text Key: 331477508
• Report Number: 3009862700-2023-01016
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/16/2024
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2023
• 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