MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRELINK; DATA MANAGEMENT SYSTEM

Model Number 71732-01

Device Problems Device Alarm System (1012); Application Program Problem (2880)

Patient Problems Hypoglycemia (1912); Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Date 02/22/2024

Event Type  Injury  

Manufacturer Narrative

An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The customer experienced a "missing high and low alarm" with the freestyle librelink application.Product quality engineering attempted to replicate the reported issue using a cellular device not identical to the actual device, but which shares relevant characteristics with the device involved and android 13 and app version 2.10.1.10406, and was not able to reproduce the complaint.There were no issues identified with the freestyle librelink app during replication that would have led to the reported issue.Section d.Suspected medical device and g4 - pma/510(k)# has been populated for the freestyle librelink android application as this report concerns a spain customer.This is same/similar to us freestyle libre 2 ios/android application part number 71857-01.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the abbott diabetes care (adc) device in use with samsung 023 phone with android operating system version 13.The low and high glucose alarms did not sound and the customer was not alerted of changes in glucose level.As a result, the customer experienced "disorientation", "memory loss", and was unable to self-treat, requiring third-party treatment of "glucagon injection" (dose unspecified) by a non-healthcare professional.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRELINK
• 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: 18863847
• MDR Text Key: 337179527
• Report Number: 2954323-2024-08035
• Device Sequence Number: 1
• Product Code: PZE
• UDI-Device Identifier: 00357599000042
• UDI-Public: 00357599000042
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P160030
• 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
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/24/2024
• Initial Date FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2024
• 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