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

Model Number 71857-01

Device Problem Application Program Problem (2880)

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

Event Date 07/31/2023

Event Type  Injury  

Event Description

A customer reported that the adc application was incompatible with their samsung galaxy a13 phone.As a result, the customer reported they were unable to obtain glucose readings and experienced a loss of consciousness.The customer was administered an unspecified iv and what they believe to be glucagon.No further details were provided.There was no report of death or permanent impairment associated with this event.

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 exact date of event is unknown.The date entered in section b3 is per the customer's report of "july." 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.

Manufacturer Narrative

An extended investigation has been performed for the reported complaint and it has been determined that there were no issues with the freestyle libre 2 application that would have led to the complaint.The customer called in reporting incompatibility device issue when using the freestyle libre 2 application.Smartphone compatibility with the use of freestyle libre 2 app 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.Successfully scanned and received glucose readings and alarm notification using similar device configuration.Therefore, this complaint is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported that the adc application was incompatible with their samsung galaxy a13 phone, app version 2.As a result, the customer reported they were unable to obtain glucose readings and experienced a loss of consciousness.The customer was administered an unspecified iv and what they believe to be glucagon.No further details were provided.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 2 APPLICATION
• 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: 17834644
• MDR Text Key: 324484339
• Report Number: 2954323-2023-42960
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193371
• 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: 71857-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• 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