MAUDE Adverse Event Report: ABBOTT LABORATORIES FREESTYLE LIBRE 14 DAY SYSTEM; SENSOR, GLUCOSE, INVASIVE

Model Number 14 DAY

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Information (3190)

Event Date 01/15/2019

Event Type  malfunction  

Event Description

I use a free style libre 14 day continuous glucose monitoring system.The sensor unexpectedly stopped working after 11 days with no warning.This is the second time this has happened.This system is not reliable and all users need to continue to have available finger pricks at all times since the sensors fail without warning.

• Brand Name: FREESTYLE LIBRE 14 DAY SYSTEM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT LABORATORIES
• MDR Report Key: 8257017
• MDR Text Key: 133714733
• Report Number: MW5083199
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/15/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 14 DAY
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR