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

Model Number 102096-67A

Device Problem Temperature Problem (3022)

Patient Problem No Code Available (3191)

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr is result of a retrospective review of complaints.The complaint is confirmed, sensor serial number (b)(4) stopped communicating during the qc test.This behavior is indicative of a damage on the asic chip.

Event Description

On (b)(6) 2019,senseonics was made aware of an incident where user called in regarding receiving high sensor temperature.A review of the diagnostic confirmed that there is an issue with the user's sensor.User was notified that sensor needed to be replaced, hence resulting in sensor removal.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown, md
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown, md
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, md
• MDR Report Key: 9983787
• MDR Text Key: 188489137
• Report Number: 3009862700-2020-00374
• Device Sequence Number: 1
• Product Code: QCD
• UDI-Device Identifier: 00817491022349
• UDI-Public: 00817491022349
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/07/2019
• Device Model Number: 102096-67A
• Device Lot Number: WP05302
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2019
• 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
• Patient Age: 36 YR