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

Model Number 101967-931

Device Problem Imprecision (1307)

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

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

The manufacturer is currently performing investigation and the results will be provided in the supplemental report.

Event Description

On january 29, 2024, senseonics was made aware of an incident where the user reported inaccurate sensor readings.

Manufacturer Narrative

Based on the initial analysis, the sensor deviated from normal behavior, showing optical instability.The rma was issued for further investigation of the sensor.The sensor was tested in-house, and the review of investigation analysis, however, the test results did not indicate any malfunction of the sensor.In an associated complaint (3009862700-2024-00048), the user's hcp reported an infection at the insertion site on february 5, 2024.This infection potentially could have impacted the sensor performance causing the reported sensor reading inaccuracy.As part of resolution, the rma was authorized for sensor replacement.Date of this report updated to 26 april 2024.Is this device available for evaluation? yes, 12 march 2024 date received by manufacturer updated to 26 april 2024.Device evaluated by manufacturer? yes.Type of investigation updated to 10.Investigation findings updated to 114.Investigation conclusions updated to 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: 18785644
• MDR Text Key: 337306665
• Report Number: 3009862700-2024-00044
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): Y
• Reporter Country Code: IS
• 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: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2024
• Device Model Number: 101967-931
• Device Catalogue Number: FG-4500-31-302
• Device Lot Number: WP09265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2023
• 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