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

Model Number 102812-81A

Device Problem Communication or Transmission Problem (2896)

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

Event Date 02/28/2024

Event Type  Injury  

Manufacturer Narrative

The user has to go back to hcp to discuss an additional procedure for removal and replacement of the sensor due to issues with sensor disconnections.No further investigation is required.

Event Description

On 29 feb 2024, senseonics was made aware of an incident where user has to go back to hcp to discuss an additional procedure for removal and replacement of the sensor due to issues with sensor disconnections.

Manufacturer Narrative

This case was created to document the user's next steps in the removal and replacement of their sensor due to constant sensor disconnections.In an associated case, the customer complained of frequent sensor disconnections.The user attempted a placement test, but the signal was still unsuccessful.A transmitter diagnostic log was requested from the user for further review.However, the customer could not provide diagnostic upload (du) because she did not have a computer.Based on the review of the user's glucose data on the data management system (dms), the user was advised to contact the hcp to discuss removal and replacement of the sensor.The potential root cause for frequent sensor disconnections could be due to the sensor being inserted too deep, resulting in weaker connection with the transmitter.B4.Date of this report updated to 12 april 2024.G3.Date received by manufacturer updated to 12 april 2024.

• 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: 19008672
• MDR Text Key: 338978780
• Report Number: 3009862700-2024-00537
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022974
• UDI-Public: 00817491022974
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 102812-81A
• Device Catalogue Number: FG-7202-00-301
• Device Lot Number: WP09730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2023
• 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
• Patient Age: 75 YR
• Patient Sex: Female