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

Model Number	72077-01
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is pending at this time.A follow up will be submitted once additional information is obtained.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device manufacturing date does not apply.The date entered in section h4 is the date abbott diabetes care became aware of the event.The operating system is unknown so product information provided is for ios.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
An issue with the abbott diabetes care (adc) application was reported.A customer reported that they attempted to scan a new sensor however, the app logged them out of their account and when they tried to reset the password, it was unsuccessful.The customer further reported experiencing a loss of consciousness and was unable to self-treat.The customer had contact with a healthcare professional who provided an unspecified treatment for the diagnosis of hypoglycemia.Adc customer service was able to reach the customer, who indicated that they were ¿not using the password requirements¿ however, they were later able to log back into the app.There was no report of death or permanent injury associated with this event.
Event or Problem Description
An issue with the abbott diabetes care (adc) application was reported.A customer reported that they attempted to scan a new sensor however, the app logged them out of their account and when they tried to reset the password, it was unsuccessful.The customer further reported experiencing a loss of consciousness and was unable to self-treat.The customer had contact with a healthcare professional who provided an unspecified treatment for the diagnosis of hypoglycemia.Adc customer service was able to reach the customer, who indicated that they were ¿not using the password requirements¿ however, they were later able to log back into the app.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
An investigation was performed for the reported complaint.The customer reported that their account was locked.Attempt to identify the customer's reported configurations and the information provided in the complaint was insufficient to conduct a comprehensive investigation.The lack of information regarding the app version, os and device make/model, it restricts the ability to identify potential causes of the customer's reported issue.Therefore, the reported issue is not confirmed due to the inadequate information provided.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 3
• Common Device Name: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda, CA 94502-7001 ; 4157205405
• MDR Report Key: 22925792
• Report Number: 2954323-2025-34652
• Device Sequence Number: 9162730
• Product Code: QLG
• UDI-Device Identifier: 00357599817008
• UDI-Public: 00357599817008
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K212132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: 72077-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown