MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SMART TRANSMITTER; IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER

Model Number 102208-751

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 01/09/2022

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Transmitter was not requested to be returned for evaluation as it was still being used by the user.Investigation was performed on user's data available in data management system (dms).Based on the investigation analysis, the reported event (the fingerstick measurement of 57 mg/dl and the corresponding sensor reading of 91 mg/dl) could not be confirmed in dms which was reported around 1:04 pm cet on (b)(6) 2022.At around 1:01 pm cet on (b)(6) 2022, the system displayed a sensor reading of 126 mg/dl and a calibration entry of 120 mg/dl.This shows the system was in good agreement with the fingerstick measurements.The overall sensor performance was within expectations.No further investigation was necessary.

Event Description

Senseonics was made aware of a hypoglycemia event due to alleged sensor inaccuracies.The reported blood glucose (bg) was 57 mg/dl where as sensor glucose (sg) was 91 mg/dl.User complained of not receiving low glucose alerts because sg value did not cross the low alert threshold that was set at 70 mg/dl.User was not symptomatic and did not require any medical attention, and was able to self treat.

• Brand Name: EVERSENSE SMART TRANSMITTER
• Type of Device: IMPLANTABLE GLUCOSE MONITORING SYSTEM, TRANSMITTER
• 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: 19009332
• MDR Text Key: 338980644
• Report Number: 3009862700-2024-00315
• 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: 03/31/2024

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: 02/22/2022
• Device Model Number: 102208-751
• Device Catalogue Number: FG-3400-51-001
• Device Lot Number: 122906
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2021
• 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