MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2 APP; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71733-01

Device Problem No Device Output (1435)

Patient Problems Loss of consciousness (2418); Convulsion/Seizure (4406)

Event Date 01/20/2023

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported encountering issues while using the freestyle librelink 2 app and experienced symptoms of seizure and a loss of consciousness.The customer was assisted in resetting their password however, refused to provide further details.No further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

An extended investigation was performed on the reported complaint and determined that there were no issues with the libre 2 application that would have led to the complaint.The customer reported that no messages showing when sensor scanned with the freestyle libre 2 application.Attempts to reproduce the issue using similar configuration and was not able to reproduce the complaint.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported encountering issues while using the freestyle librelink 2 app in use with samsung ultra 22, os version: 13, software full version: 2.7.2.7077 and experienced symptoms of seizure and a loss of consciousness.The customer was assisted in resetting their password however, refused to provide further details.No further information was provided.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 2 APP
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 16378965
• MDR Text Key: 309573896
• Report Number: 2954323-2023-06912
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71733-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other