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

Model Number 102208-904

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 07/19/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The initial investigation was performed on the user synced glucose data on data management system (dms), which is an eversense cloud platform.Based on the initial investigation analysis, it was observed that the sensor was taking longer than usual (after insertion) and there were multiple mismatches observed between (b)(6) 2023 and (b)(6) 2023.Due to this deviation in the sensor performance and to investigate the issue further, a return material authorization (rma) was issued for the return and replacement of sensor.As part of the standard returned product analysis, a sensor functional performance test was performed on the returned sensor following the decontamination process.This test measures the sensor's fluorescence characteristics with respect to changes in glucose solution concentrations and temperature changes, and compares the results to the performance measured during the initial manufacturing of the same sensor.A review of the test results did not reveal any malfunction.Hence, the root cause of the issue cannot be conclusively determined based on the returned product analysis.In some instances, the failure mode (sensor performance) that presents itself in the body cannot be reproduced in the lab upon returned product analysis mainly as the test conditions do not replicate the exact conditions in-vivo at the time of failure, and the explant and subsequent decontamination of the product might also alter the state of the sensor.Based on historical data of similar incidents, the potential root cause of the issue could be attributed to insufficient hydration of chemical component of the sensor.

Event Description

Senseonics was made aware of an incident where the customer experienced a hyperglycemia event on (b)(6) 2023 at 11:08 pm.The customer reported that sensor glucose (sg) was 168 mg/dl where as the measured blood glucose (bg) value was 230 mg/dl.The customer complained of not receiving a high glucose alert.The customer did not seek any medical attention and self resolved the event by injecting insulin.

• 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: 18117229
• MDR Text Key: 327882802
• Report Number: 3009862700-2023-00281
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/12/2023
• Device Model Number: 102208-904
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09042
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2022
• 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