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 01/15/2024

Event Type  malfunction  

Event Description

On january 8, 2024, senseonics was made aware of an incident where a user experienced sensor inaccuracy which led to early sensor removal.

Manufacturer Narrative

This mdr is a result of retrospective review of complaints.The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Manufacturer Narrative

Based on the initial escalation analysis, the sensor performance deviated from the normal behavior with mismatches observed between the sensor readings and the calibration entries.An rma was authorized to investigate the sensor further, but by the closing of this complaint record, the sensor has not been received.In an associated complaint ((b)(4)), the user's hcp reported an infection at the insertion site on (b)(6) 2024.This infection potentially could have impacted the sensor performance causing the reported sensor reading inaccuracy.B4.Date of this report updated to (b)(6) 2024.G3.Date received by manufacturer updated to (b)(6) 2024.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 4114.H6.Investigation findings updated to 213.H6.Investigation conclusions updated to 67.

• 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: 18764438
• MDR Text Key: 336560631
• Report Number: 3009862700-2024-00029
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/03/2024
• Device Model Number: 101967-931
• Device Catalogue Number: FG-4500-31-302
• Device Lot Number: WP09511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• 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