MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2 APP; DATA MANAGEMENT SYSTEM

Model Number 71732-01

Device Problems Image Display Error/Artifact (1304); Unable to Obtain Readings (1516)

Patient Problems Hyperglycemia (1905); Loss of consciousness (2418)

Event Date 08/17/2022

Event Type  Injury  

Event Description

A complaint was received regarding an "unexpected application error" message from freestyle libre 2 application.As a result of not being able to log into the app to scan the sensor, on (b)(6) 2022, the customer had a loss of consciousness and was provided insulin by a non-healthcare professional for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The product data has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.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.

Manufacturer Narrative

The reported complaint is an account password reset issue with the freestyle libre 2 version 2.7.2 app.The user received a message "unexpected application error" when pressing the "forgot password" link.An investigation was performed and determined that this was due to r8 obfuscation (the default compiler that converts java bytecode into the dex format that runs on the android platform.Obfuscation is used to reduce the size of the application by shortening the name of the classes and members¿ attributes), which had a conflict with the network library ¿retrofit¿.This caused an issue with the network call used to reset the password.Therefore, the complaint is confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A complaint was received regarding an "unexpected application error" message from freestyle libre 2 application.(b)(6) 2022, the customer had a loss of consciousness and was provided insulin by a non-healthcare professional for treatment.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: DATA MANAGEMENT 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: 15340602
• MDR Text Key: 299142148
• Report Number: 2954323-2022-32064
• 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: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71732-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female