MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. ABBOTT FREESTYLE LIBRE 14 CONTINUOUS GLUCOSE MONITOR; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number FREESTYLE LIBRE 14 READER & SENS

Device Problem Loss of Data (2903)

Patient Problem No Information (3190)

Event Date 12/30/2018

Event Type  malfunction  

Event Description

Failure of data recording correlated with manual sensor reads.At 08:25 hrs a manual sensor read was performed on (b)(6) 2018.Correlated with this manual sensor read, the sensor failed to make its glucose measurements at 15 min intervals leaving a data gap for the next 1 hour and 35 mins.This is a reliability problem with the sensor and creates issues of confidence in this device.Multiple data gap problems occur during the 14 day use cycle for a sensor.Other reports for subsequent sensor failures will be filed.Ref # mw5083353, mw5083355, mw5083356, mw5083357, mw5083358, mw5083359, mw5083360, mw5083361, mw5083362.

• Brand Name: ABBOTT FREESTYLE LIBRE 14 CONTINUOUS GLUCOSE MONITOR
• Type of Device: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 8277607
• MDR Text Key: 134309058
• Report Number: MW5083354
• Device Sequence Number: 0
• Product Code: NBW
• 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: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Model Number: FREESTYLE LIBRE 14 READER & SENS
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 91