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

Model Number	71732-01
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Hypoglycemia (1912); Convulsion/Seizure (4406)
Date of Event	09/15/2025
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.Section d.Suspected medical device and g4 - pma/510(k)# has been populated for the freestyle librelink android application as this report concerns a finland customer.This is same/similar to us freestyle libre 2 android application, model number 71857-01.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
An incompatible application issue was reported with the abbott diabetes care (adc) device in use with a samsung galaxy a14 with android operating system version 15.The customer stated the low glucose alarm did not appear.As a result, the customer was unable to monitor glucose with sensor readings and experienced seizures and a fall, where they bruised their left elbow while crawling.The customer was able to self-treat with food.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
An investigation was performed for the reported complaint.The customer reported for no alarms were received.Attempted 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 operating system, 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.
Event or Problem Description
An incompatible application issue was reported with the abbott diabetes care (adc) device in use with a samsung galaxy a14 with android operating system version 15 and app version 2.12.1.11476.The customer stated the low glucose alarm did not appear.As a result, the customer was unable to monitor glucose with sensor readings and experienced seizures and a fall, where they bruised their left elbow while crawling.The customer was able to self-treat with food.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: 23398034
• Report Number: 2954323-2025-42354
• Device Sequence Number: 9979237
• Product Code: PZE
• UDI-Device Identifier: 00357599000042
• UDI-Public: 00357599000042
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 11/06/2025

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: 71732-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/06/2025
• 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: Other
• Patient Sex: Unknown