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	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	09/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An application compatibility issue was reported with the abbott diabetes care (adc) device in use with an iphone (unknown model) with ios operating system version 18.6.2.Due to the reported issue, the customer did not receive alarms, experienced hypoglycemia, a loss of consciousness, and fell which resulted in a head injury.The customer was taken to the hospital and reportedly, treated their head and ¿everything was okay¿.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
Investigation is pending at this time.A follow up will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Additional Manufacturer Narrative
The user reported incompatible os.The reported issue was investigated.The reported configuration was not compatible with the customer's reported application.The latest revision of the compatibility guide was available to the customer on the abbott diabetes care website.As the compatibility guide is provided to the customer and the incompatible configurations were used, this complaint is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
An application compatibility issue was reported with the abbott diabetes care (adc) device in use with an iphone (unknown model) with ios operating system version 18.6.2 and app version 2.12.2.8979.Due to the reported issue, the customer did not receive alarms, experienced hypoglycemia, a loss of consciousness, and fell which resulted in a head injury.The customer was taken to the hospital and reportedly, treated their head and ¿everything was okay¿.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: 23224988
• Report Number: 2954323-2025-39756
• Device Sequence Number: 13121953
• Product Code: PZE
• UDI-Device Identifier: 00357599000059
• UDI-Public: 00357599000059
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 10/13/2025

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: 10/02/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 10/15/2025
• 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