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

Model Number 102208-751

Device Problem Imprecision (1307)

Patient Problem Hypoglycemia (1912)

Event Date 10/25/2021

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The investigation was performed on the user synced glucose data in data management system (dms), which is a cloud platform for eversense systems.Based on the investigation analysis, there was temporary mismatch between the sensor readings and fingerstick measurements on october 25 at around 8 am cet which most likely resulted in missed alerts.Following the reported event, the system displayed good agreement between the sensor readings and fingerstick measurements.

Event Description

Senseonics was made aware of an incident where patient reported a hypoglycemia event because of sensor inaccuracies.Blood glucose value was 40 mg/dl where as sensor glucose (sg) was 105 mg/dl.Patient took help from her daughter to treat and resolve the issue.Patient did not require any medical intervention.

• Brand Name: EVERSENSE TRANSMITTER
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown 20876-7005
• MDR Report Key: 18998683
• MDR Text Key: 338878685
• Report Number: 3009862700-2024-00270
• Device Sequence Number: 1
• Product Code: QHJ
• Combination Product (y/n): N
• 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

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/23/2022
• Device Model Number: 102208-751
• Device Catalogue Number: FG-3400-51-001
• Device Lot Number: 122906
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other