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

Model Number 71857-01

Device Problem Application Program Version or Upgrade Problem (2881)

Patient Problems Fatigue (1849); Hypoglycemia (1912); Nausea (1970); Diaphoresis (2452)

Event Date 01/12/2023

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 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 a "reset password" error while using the freestyle librelink.The customer experienced symptoms of sweating, dizziness, exhaustion, and nausea and was unable to self-treat.The customer had contact with a healthcare professional who provided glucose injection, glucose pill and orange juice for the diagnosis of hypoglycemia.No further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The user reported password issue with the application.The user can reset the account password by selecting "forgot password" in the app or libreview website and following the provided instructions.An investigation was performed for the reported complaint was able to create a new account, reset the account password and log in to the app successfully, and was not able to reproduce the complaint.Therefore, this complaint is not confirmed.All pertinent information available to abbott diabetes care has been submitted.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.

Event Description

A customer reported encountering a "reset password" error while using the freestyle librelink.The customer experienced symptoms of sweating, dizziness, exhaustion, and nausea and was unable to self-treat.The customer had contact with a healthcare professional who provided glucose injection, glucose pill and orange juice for the diagnosis of hypoglycemia.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: 16426318
• MDR Text Key: 310045102
• Report Number: 2954323-2023-07821
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210943
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71857-01
• Device Catalogue Number: 71857-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• 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 Age: 64 YR
• Patient Sex: Male