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

Model Number 102208-750

Device Problem Imprecision (1307)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 03/28/2022

Event Type  Injury  

Event Description

On march 29, 2022, senseonics was made aware of a hyperglycemia event due to alleged sensor inaccuracies on (b)(6) 2022.The user was admitted to intensive care unit because of high glucose.The blood glucose (bg) measurement was 700 mg/dl whereas the sensor glucose (sg) was 200 mg/dl.The user was diagnosed with ketoacidosis and was in icu until (b)(6) 2022, when he was discharged.The user's hcp is aware of the event.

Manufacturer Narrative

This report is being submitted retrospectively as part of an internal review.The transmitter was not requested to be returned for evaluation as it was still being used by the user.The investigation was performed on the user's data available in data management system.The customer's complaint of the event on (b)(6) 2022 cannot be confirmed, as the referenced sg and bg values were not found in the data for that day.Though the investigation didn't find any malfunction with the sensor, it revealed that the customer was not properly calibrating the system, which likely would have prevented the system from adjusting correctly for better accuracy.

• Brand Name: EVERSENSE TRANSMITTER
• 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: 18435842
• MDR Text Key: 331797782
• Report Number: 3009862700-2023-00758
• 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: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/28/2021
• Device Model Number: 102208-750
• Device Catalogue Number: FG-3400-50-001
• Device Lot Number: 121892
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2021
• 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): Hospitalization