MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRELINK; DATA MANAGEMENT SYSTEM

Model Number	71733-01
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Codes	Hyperglycemia (1905); Loss of consciousness (2418)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The customer reported being unable to access account due to password issue and was investigated.After attempting to identify the customer's reported configurations, the information provided in the complaint was insufficient to conduct a comprehensive investigation.The lack of the app version, operating system and device 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.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 was reported with the abbott diabetes care (adc) application in use with unknown phone, unknown operating system and version.The customer was unable to access the application and unable to monitor glucose readings due to password problem.At this point, without measuring their blood sugar, the customer self-injected with two doses of insulin (type unspecified).However, the customer experienced loss of consciousness, fell, and was taken to a hospital.The customer underwent various tests such as ct scan, blood sample and was provided unspecified heart medicine, unspecified intravenous drip, and insulin (type/dose unspecified) by a healthcare professional as treatment.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRELINK
• Common Device Name: DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda 94502 7001
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda 94502-7001 ; 4157205405
• MDR Report Key: 22938597
• Report Number: 2954323-2025-35107
• Device Sequence Number: 10107271
• Product Code: PZE
• UDI-Device Identifier: 00357599000059
• UDI-Public: 00357599000059
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P160030
• 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
• Report Date (Section B): 09/02/2025

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: 71733-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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