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

Model Number 71732-01

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

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

Event Date 08/19/2023

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 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 motorola g40 with android operating system version 12.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 a loss of consciousness and was unable to self-treat, requiring third party administration of oral glucose.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Smartphone compatibility with the use of freestyle librelink app and the motorola moto g40 device has not been tested at the time of the investigation.The compatibility guide states that abbott diabetes care has not assessed compatibility on phone/operating systems other than those listed.Attempted to replicate the user¿s complaint using similar configuration and successfully receive high and low glucose alarms on a samsung galaxy s20 (android 13, 2.10.1.10406) using a known good libre 2 sensor, and was unable to reproduce the complaint.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 motorola g40 with android operating system version 12 and app version 2.10.1.10406.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 a loss of consciousness and was unable to self-treat, requiring third party administration of oral glucose.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• 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: 17684162
• MDR Text Key: 322650482
• Report Number: 2954323-2023-38942
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599000042
• UDI-Public: 00357599000042
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/19/2023

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: 08/22/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• 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