MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LIBRE 2 READER; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE WITH AUTOMATED INSULIN DELIVERY SYSTEMS

Catalog Number 71953-01

Device Problem Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2021

Event Type  malfunction  

Event Description

Abbott labs cgm reader for freestyle libre system sent a loss is signal alarm 6 times within a 2hour time span even though the reader was in my pocket.This is an ongoing problem which i have tried to report to abbott many times.I have used this system since it first became available and have become accustomed to the fact that there will be several loss of signal alarms each day, even though the reader is in my pocket.I have tried leaving the reader on a table in a room where i am sitting within 10 feet of the reader, but the problem is the same.Occasionally there is a loss of signal alarm at night, but this happens infrequently.As i am a brittle type 1 diabetic, i do not want to turn off the loss of signal alarm as the sound is the same as the low blood sugar alarm.Fda safety report id #: (b)(4).

• Brand Name: FREESTYLE LIBRE 2 READER
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE WITH AUTOMATED INSULIN DELIVERY SYSTEMS
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.
• MDR Report Key: 11776628
• MDR Text Key: 249435694
• Report Number: MW5101162
• Device Sequence Number: 1
• Product Code: QLG
• 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: 05/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 71953-01
• Device Lot Number: 04A198D
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 72