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

Model Number 102208-751

Device Problem Imprecision (1307)

Patient Problem Hyperglycemia (1905)

Event Date 02/11/2022

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The investigation was performed on the user's data available in data management system (dms).The investigation did not confirm the reported mismatch between bg and sg on 11th february 2022 as reported.However, a slightly high mard was observed around that period.It's unclear what the root cause was, however, there was a pattern which suggested there might have been an issue with test strips and/or contaminated bg value due to wet fingers.A review of the data in a 2-week time range and beyond didn't reveal any malfunction of the sensor, and further review of the in-vivo data shows that the system continued to function properly with reduced mard values and successfully lasted the expected 180 days.No further investigation was possible for this complaint.

Event Description

Senseonics was made aware of a hyperglycemia event due to alleged sensor inaccuracies.The reported blood glucose (bg) was 245 mg/dl where as sensor glucose (sg) was 144 mg/dl.User complained of not receiving high glucose alerts because sg value did not cross the high alert threshold that was set at 185 mg/dl.User was symptomatic (feeling thirsty, needed to use restroom).However, user did not require any medical attention, and was able to self treat.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 18908186
• MDR Text Key: 337730307
• Report Number: 3009862700-2024-00325
• Device Sequence Number: 1
• Product Code: QCD
• 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
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/25/2022
• Device Model Number: 102208-751
• Device Catalogue Number: FG-3400-51-001
• Device Lot Number: 123108
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2021
• 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