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 03/03/2022

Event Type  Injury  

Event Description

Senseonics was made aware of a hyperglycemia event due to alleged sensor inaccuracies on (b)(6) 2022.The reported blood glucose (bg) was 300 mg/dl where as sensor glucose (sg) was not provided.User complained of not receiving high glucose alerts.User stated they were not symptomatic, did not require medical treatment and was able to self treat.

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 (b)(6) 2022 as reported.However, a slightly high mard was observed around that period, and is likely since customer was taking a drug of tetracycline class which may falsely lower sensor glucose readings as indicated in our user manual.No further investigation is required.

• 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: 18997743
• MDR Text Key: 338875046
• Report Number: 3009862700-2024-00332
• 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: 03/28/2024

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: 12/30/2021
• Device Model Number: 102208-751
• Device Catalogue Number: FG-3400-51-001
• Device Lot Number: 121946
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/30/2020
• 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