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

Model Number 101967-931

Device Problem Failure to Sense (1559)

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

Event Date 09/10/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.The sensor replacement alert was first presented to the user on (b)(6) 2023, day 45 after insertion.An rma was authorized to investigate the sensor further.From the return material analysis testing, however, the sensor did not reveal any malfunction.The failure mode could not be reproduced, and this may occur in some instances where the failure mode that presents itself in the body could not be reproduced in the lab.Upon review of the glucose plot, there were two consecutives drop out phases within 14 days of each other on (b)(6) 2023.Further analysis of the in vivo glucose data shows that the rate of change in the glucose values frequently exceeded 5mg/dl/min.The potential root cause 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 which is not reproduced in the lab.As part of resolution, the rma was authorized to offer the user a sensor replacement.

Event Description

On september 11, 2023, senseonics was made aware of an incident where user received an early sensor replacement alert resulting in an early sensor removal.

• 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: 18394262
• MDR Text Key: 331672673
• Report Number: 3009862700-2023-00969
• 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
• Report Date: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/22/2023
• Device Model Number: 101967-931
• Device Catalogue Number: FG-4500-31-302
• Device Lot Number: WP09237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2023
• 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