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

Model Number 102208-600

Device Problem Imprecision (1307)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 01/05/2023

Event Type  malfunction  

Manufacturer Narrative

The manufacturer is currently performing an investigation and will provide the results with the supplemental report.

Event Description

On (b)(6) 2023, senseonics was made aware of an adverse event where user experienced hypoglycemia due to inaccuracies in sensor readings.

Manufacturer Narrative

H6.Clinical code corrected to 1905.

Event Description

On 06 january 2023, senseonics was made aware of an adverse event where user experienced false hyperglycemia alerts due to inaccuracies in sensor readings.

Manufacturer Narrative

Based on the investigation analysis, it was confirmed that the system displayed a temporary mismatch between the blood glucose and sugar glucose measurements at the time of the incident.The sensor data was reviewed from the prior two weeks and there was no indication of any sensor performance issue, as the sensor readings closely matched the calibration entries.The exact cause of the temporary mismatch at the time of the event could not be determined and there were no signs of sensor malfunction.Temporary mismatch could occur if past calibrations entered were not accurate, or the calibration on the day of the event was reported in error, or it could be due to occasional differences that the system produces.The overall sensor performance was evaluated, and it was performing within expectations.The user ate something to increase her glucose levels.The user is currently using the system with up-to-date information.The current system performance is within expectations.H3: device evaluated by manufacturer? yes.H6: investigation findings updated to 114.H6: investigation conclusions updated to 4315.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20875 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20875-7005
• MDR Report Key: 16280543
• MDR Text Key: 308606163
• Report Number: 3009862700-2023-00020
• Device Sequence Number: 1
• Product Code: QHJ
• UDI-Device Identifier: 00817491022912
• UDI-Public: 817491022912
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/25/2023
• Device Model Number: 102208-600
• Device Catalogue Number: FG-5900-01-001
• Device Lot Number: 129860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic