MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRELINKUP; CONTINUOUSE GLUCOSE MONITORING RETROSPECTIVE DATA ANALYSIS SOFTWARE

Model Number	72154-01
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported data sharing no longer functions after update.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 device and app version 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 date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A complaint via email was received.An application issue was reported with the abbott diabetes care (adc) device in use with an unknown phone with an ios operating system version.The customer indicated that the librelinkup application seems to not be working at all on ios.It appears that this issue started right after upgrading the phone and watch to version 26.1.As a result, the customer was unable to monitor glucose using sensor readings and experienced a loss of consciousness.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRELINKUP
• Common Device Name: CONTINUOUSE GLUCOSE MONITORING RETROSPECTIVE DATA ANALYSIS SOFTWARE
• 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 94502-7001 ; 4157205405
• MDR Report Key: 23646770
• Report Number: 2954323-2025-46088
• Device Sequence Number: 21363096
• Product Code: PJT
• UDI-Device Identifier: 00357599824006
• UDI-Public: 00357599824006
• Combination Product (Y/N): N
• Initial Reporter Country: QA
• PMA/510(K) Number: VERIFY
• 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): 11/25/2025

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: 72154-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/25/2025
• 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