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

Model Number 101967-950

Device Problem Failure to Sense (1559)

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

Event Date 06/10/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Sensor (b)(6) was returned for sensor replacement alert with error code (ec1).Ec1 was first presented to the customer on 10th june 2023 (day 115 since insertion).Qc testing of the returned sensor revealed a loss of chemical performance.In-vivo data also showed diminished metric of sensor performance (msp) indicator value throughout the insertion period.The system correctly disabled the sensor due to performance failure, and the system's self-test functions are working normally.The root cause of such failures are attributed to sensor's hydrogel oxidation.As part of resolution, the rma was issued for sensor replacement.No further investigation was found necessary for this complaint.

Event Description

Senseonics was made aware of an incident where the user received an early sensor replacement alert resulting in early sensor removal.The user received the alert on 10 june 2023, on day 118 of sensor life.No adverse events were associated with this complaint.

• 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: 19009383
• MDR Text Key: 339125621
• Report Number: 3009862700-2024-00462
• 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
• Report Date: 03/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/17/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09010
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1