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

Model Number 71857-01

Device Problem Application Program Problem (2880)

Patient Problems Bruise/Contusion (1754); Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 04/06/2023

Event Type  Injury  

Manufacturer Narrative

The product data has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported an issue with the adc application.As a result, the customer experienced symptoms of hypoglycemia, a loss of consciousness, and consequently "had a bump left and right of forehead, bump on chin, bruises on left side of forearm, bruises on right lower log, and lost a tooth".Customer reported being able to self-treat and went to a dentist for dental care.No further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The user reported that they are missing low glucose alarm in freestyle libre 3 app.Attempts to replicate the users complaint using a similar configuration.Investigation was unable to replicate the complaint therefore, the issue is not confirmed.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.

Event Description

A customer reported an issue with the adc application.As a result, the customer experienced symptoms of hypoglycemia, a loss of consciousness, and consequently "had a bump left and right of forehead, bump on chin, bruises on left side of forearm, bruises on right lower log, and lost a tooth".Customer reported being able to self-treat and went to a dentist for dental care.No further information was provided.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH 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: 16766405
• MDR Text Key: 313557515
• Report Number: 2954323-2023-14963
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71857-01
• Device Catalogue Number: 71857-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other