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 01/29/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Senseonics was made aware of an incident where the user complained of inaccurate sensor readings which resulted in early sensor removal due to a potential malfunction.No adverse events were associated with this incident.The sensor was inserted on (b)(6) 2023 and the incident occurred on 29 january 2023.

Manufacturer Narrative

Based on the initial analysis, there were multiple sensor check alerts asserted at the time of the event during the early sensor wear period.The rma was issued for further investigation of the sensor.The investigation revealed optical instability.The potential root cause for the reported failure mode may be related to an issue with the led behavior at the time of the event.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 26 april 2023 g.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: 19009301
• MDR Text Key: 339127202
• Report Number: 3009862700-2024-00419
• 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,Followup
• Report Date: 04/11/2024

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: 06/30/2023
• Device Model Number: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09004
• 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: 07/25/2022
• 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