MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD LIBRE 3 APP FREESTYLE; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 72077-01

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

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 09/06/2023

Event Type  Injury  

Manufacturer Narrative

The customer¿s product data has been requested for investigation.A follow-up report will be filed once additional information is obtained.The device manufacturing 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 adc device in use with oneplus 10 phone with android 13 operating system version 3.4.2.9593.The low glucose alarm did not sound, and customer was not alerted of changes in glucose level.As a result, the customer experienced low sugar, a loss of consciousness and an ambulance was called, and customer received third-party administration of glucose injection for a diagnosis of hypoglycemia.No further treatment was reported.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The freestyle libre 3 complaint was investigated and determined that there were no issues with the freestyle libre 3 application that would have led to the complaint.The customer reported missing low glucose alarm.Attempted to replicate the user¿s complaint using samsung galaxy s20 (android 13 ,3.4.2.9593) and the system functioned as intended.The user complaint could not be reproduced.Therefore, this complaint is not confirmed.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 oneplus 10 phone with android 13 operating system version 3.4.2.9593.The low glucose alarm did not sound, and customer was not alerted of changes in glucose level.As a result, the customer experienced low sugar, a loss of consciousness and an ambulance was called, and customer received third-party administration of glucose injection for a diagnosis of hypoglycemia.No further treatment was reported.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 it has been determined that there were no issues identified with the freestyle libre 3 application during replication that would have led to the reported issue.The customer reported missing low glucose alarm.Attempted to replicate the customer's complaint using similar configurations samsung galaxy s20 (android 13 , 3.4.2.9593) and the reported issue was unable to be replicated and the system functioned as intended.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.Section h10 (addtl mfg narrative) and h6 (adverse event problem) were incorrectly documented in the #1 follow up report.The correction has been made here.

Event Description

An alarm issue was reported with the adc device in use with oneplus 10 phone with android 13 operating system version 3.4.2.9593.The low glucose alarm did not sound, and customer was not alerted of changes in glucose level.As a result, the customer experienced low sugar, a loss of consciousness and an ambulance was called, and customer received third-party administration of glucose injection for a diagnosis of hypoglycemia.No further treatment was reported.There was no report of death or permanent impairment associated with this event.

• Brand Name: LIBRE 3 APP FREESTYLE
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 17897573
• MDR Text Key: 325232361
• Report Number: 2954323-2023-44907
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K213996
• 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,Followup
• Report Date: 01/09/2024

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: 72077-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 11/14/2023; 01/03/2024
• Supplement Dates FDA Received: 11/23/2023; 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2023
• 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