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 08/28/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Based on the initial escalation analysis, the sensor (b)(6) had deviated from normal behavior.An rma for the sensor was issued for further investigation.The returned sensor was tested in-house, and a qc test did not reveal any malfunction of the sensor.This may occur in instances where the failure mode that presents itself in the body is not reproduced in the lab.The user only synced his data to data management system (dms) from (b)(6) 2023 through (b)(6) 2023 which was not sufficient to perform a thorough dms analysis.Based on this limited data, we observed that the reference channel was approximately 30% of the post-graft reference value.If the reference is too low, the algorithm correction would not happen as it should, and inaccuracies may be observed.One of the potential root cause could be due to user experiencing a micro-injury at the insertion site.

Event Description

Senseonics was made aware of an incident where the customer complained of inaccurate sensor readings which resulted in early sensor removal.No adverse events were associated with this incident.

• 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: 19009382
• MDR Text Key: 338989269
• Report Number: 3009862700-2024-00504
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491023308
• UDI-Public: 817491023308
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 10/12/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09045
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1