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

Model Number 101967-950

Device Problem Imprecision (1307)

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

Event Date 10/04/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Manufacturer is currently performing investigation and results will be provided in a supplemental report.

Event Description

Senseonics was made aware of an incident where the customer complained of inaccurate sensor readings which resulted in early sensor removal.

Manufacturer Narrative

Based on the initial escalation analysis, the sensor performance deviated from normal behavior.An rma was authorized for further investigation.Upon receipt of the sensor, the return product analysis testing was performed, however, the failure mode could not be reproduced.This may occur in some instances where the failure mode that presents itself in the body is not reproduced in the lab.The potential root cause for the reported failure mode may be related to an issue with the sensor electronics, for example the led behavior at the time, or the in vivo state of the sensor hydrogel.As part of resolution, the rma was authorized for sensor replacement.B4.Date of this report updated to 11 april 2024.D9 device available for evaluation? yes,device received on 17 jan 2023.Date received by the manufacturer ? 09 april 2024.H3.Device evaluated by manufacturer? yes.H6.Type of investigation updated to 10.H6.Investigation findings updated to 4203.H6.Investigation conclusions updated to 4307.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 19009057
• MDR Text Key: 339254753
• Report Number: 3009862700-2024-00382
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP08952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2022
• 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