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); Dizziness (2194); Loss of consciousness (2418)

Event Date 03/13/2024

Event Type  Injury  

Event Description

An alarm issue was reported with the abbott diabetes care adc device in use with nokia g605g with android operating system version 13.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced dizziness and a loss of consciousness.The customer was unable to self-treat and was given jelly bellies and 2 glasses of orange juice by a non-healthcare professional.There was no report of death or permanent impairment associated with this event.

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 missing high/low glucose alarms with freestyle librelink application.The reported issue was unable to be replicated as the reported configuration of nokia g605g is not compatible with the freestyle librelink app.As the compatibility guide is provided to the customer and the incompatible configurations were used, this complaint is not confirmed to use.The device manufacturing date does not apply.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.

• Brand Name: FREESTYLE LIBRELINK
• Type of Device: DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 18963252
• MDR Text Key: 338429043
• Report Number: 2954323-2024-09819
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• 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: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2024
• 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