MAUDE Adverse Event Report: SENSEONICS, INCORPORATED EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number 101967-950

Device Problems Imprecision (1307); Chemical Problem (2893); Device Ingredient or Reagent Problem (2910)

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

Event Date 07/23/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The sensor was tested in-house, and the review of investigation analysis revealed a loss of chemical performance, resulting in the sensor performance deviation.The root cause of the performance failure (inaccurate readings) was due to oxidation of the chemical component of the sensor.As part of resolution, a return material authorization was issued for sensor replacement.No further resolution was necessary for this complaint.

Event Description

On (b)(6) 2023, senseonics was made aware of an incident where the user experienced sensor inaccuracy which led to early sensor removal.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS, INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS, INCORPORATED; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 19001501
• MDR Text Key: 338991819
• Report Number: 3009862700-2024-00479
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• 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
• Date Returned to Manufacturer: 09/21/2023
• Date Manufacturer Received: 07/25/2023
• 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
• Patient Outcome(s): Other