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

Model Number 102204-005

Device Problem Calibration Problem (2890)

Patient Problem Hypoglycemia (1912)

Event Date 08/10/2019

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.The system went into initialization phase due to expired calibration and therefore the sensor glucose readings were blinded.During re-initialization phase, the system will not assert any hypo alerts until completion of the 2nd calibration entry.This is expected/normal device behavior.Furthermore, the device was not received for analysis even though it was requested.Based on the investigation conducted on the available data, the system showed normal behavior.Patient felt fine after drinking coca cola.

Event Description

User experienced a hypoglycemic event and was not alerted by the his smart phone nor did he receive a vibration from his transmitter.

• 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: 18263859
• MDR Text Key: 329667433
• Report Number: 3009862700-2023-00402
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: AU
• 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: 12/04/2023

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: 10/24/2019
• Device Model Number: 102204-005
• Device Catalogue Number: FG-3400-XX-XXX
• Device Lot Number: 110340
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2019
• Initial Date FDA Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2018
• 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