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 Fatigue (1849); Hypoglycemia (1912); Vomiting (2144)

Event Date 12/25/2023

Event Type  Injury  

Manufacturer Narrative

Extended investigation is pending at this time.A follow up will be submitted once additional information is obtained.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.

Event Description

An alarm issue was reported with the adc device in use with a samsung sm-a528b phone with an android operating system version 13.The low glucose alarms did not sound, and customer was not alerted of changes in glucose level.As a result, the customer experienced vomiting, felt cold, and weakness while standing up.Customer was seen by a healthcare professional and was administered a glucose injection as treatment.There was no report of death or permanent impairment associated with this event.

Event Description

An alarm issue was reported with the adc device in use with a samsung sm-a528b phone with an android operating system version 13, app version 2.10.1.10406.The low glucose alarms did not sound, and customer was not alerted of changes in glucose level.As a result, the customer experienced vomiting, felt cold, and weakness while standing up.Customer was seen by a healthcare professional and was administered a glucose injection as treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The freestyle libre 2 app complaint was investigated and determined that there were no issues with the freestyle libre 2 app that would have led to the complaint.The user reported missing high and low glucose alarms.Attempted to replicate the user¿s complaint using similar configuration of [samsung galaxy s20 fe 5g, android 13, 2.10.1.10406] and the reported issue was unable to be replicated and the system functioned as intended.Therefore, this complaint is not confirmed.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 CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 18452409
• MDR Text Key: 332184946
• Report Number: 2954323-2024-00450
• Device Sequence Number: 1
• Product Code: PZE
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2023
• 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