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

Model Number 101967-950

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 06/25/2023

Event Type  Injury  

Event Description

Senseonics was made aware of an incident where the customer experienced a false hyperglycemia event on (b)(6) 2023 at 01:07 pm.The customer reported that sensor glucose (sg) was 20,1 mmol/dl where as the measured blood glucose (bg) value was 8,3 mmol/dl.The customer complained of receiving a high glucose alert when there was no such symptoms and the measured bg value was in normal glucose range.The customer did not have to take any action because there were no symptoms.

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, the customer reported false hyperglycemia event on (b)(6) 2023 at the time of event was confirmed.A diagnostic upload was requested from the customer to do further investigation, and it indicated that the sensor performance had deviated from the normal behavior due to noise in sensor readings.A sensor replacement alert was also triggered at the time by the system when its diagnostics determined that sensor performance is not acceptable to be providing glucose values.To further investigate the issue and to determine the root cause, a return material authorization (rma) was issued for the return and replacement of sensor.The investigation of the returned sensor, however, did not reveal any malfunction.This may occur in instances where the failure mode that presents itself in the body cannot be reproduced in the lab.The customer had reported that there was infection at the insertion site, which could potentially be the root cause of the in-vivo glucose reading noise leading to the performance failure.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 18117359
• MDR Text Key: 327880175
• Report Number: 3009862700-2023-00275
• 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: 11/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2023
• 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: 101967-950
• Device Catalogue Number: FG-4500-50-302
• Device Lot Number: WP09082
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/25/2023
• 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