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 Codes	Hypoglycemia (1912); Confusion/ Disorientation (2553); Convulsion/Seizure (4406)
Date of Event	10/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An unexpected application issue was reported with the abbott diabetes care (adc) application, in use with iphone xr with ios operating system version 17.6.1.The customer's freestyle librelinkup application was "not receiving information" from freestyle libre 3 application.As a result, the caregiver was not notified via the freestyle librelinkup application of customer's glycemic status.The customer experienced confusion, convulsions, seizure and was unable to self-treat.The customer received oral glucose from a family member and juice from a healthcare professional as treatment.There was no report of death or permanent impairment associated with this event.
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 that the freestyle librelinkup application was not receiving information from freestyle libre 3 application.Per the abbott diabetes care compatibility guide, the reported configuration of ios 17.6.1 is not compatible with the customer's reported application.The latest revision of the compatibility guide is 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.The device manufacturing date does not apply.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

• 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: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 20695895
• Report Number: 2954323-2024-45216
• Device Sequence Number: 17780955
• Product Code: PJT
• UDI-Device Identifier: 00357599824006
• UDI-Public: 00357599824006
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 11/15/2024

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: 11/07/2024
• Initial Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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