MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRELINKUP; FLASH GLUCOSE MONITORING SYSTEM

Model Number	72154-01
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Codes	Hypoglycemia (1912); Brain Injury (2219); Loss of consciousness (2418)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
An email complaint was received in which an unexpected application issue was reported with the abbott diabetes care (adc) application, in use with nothing phone 1 with android operating system version 13.The customer's freestyle librelinkup application was showing "unexpected application error" message.The caregiver was unsure whether the other user of the same account turned off their notifications or acknowledged the alert without taking action, and if this affected the main user's application.As a result, the caregiver was not notified via the linkup application of customer's glycemic status.The customer experienced hypoglycemia and loss of consciousness.This led them being taken to a hospital, where they were diagnosed with obstructive sleep apnea, reportedly resulted "brain damage" and received unspecified treatment by a healthcare professional (hcp).Hcp suspected that this might have been caused by the hypoglycemia, but they could not confirm a direct link.At the same time, they were unable to determine any other specific cause for the sleep apnea and "brain damage".There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
Extended investigation is pending at this time.A follow up will be submitted once additional information is obtained.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.
Event or Problem Description
An email complaint was received in which an unexpected application issue was reported with the abbott diabetes care (adc) application, in use with nothing phone 1 with android operating system version 13 and unknown app version.The customer's freestyle librelinkup application was showing "unexpected application error" message.The caregiver was unsure whether the other user of the same account turned off their notifications or acknowledged the alert without taking action, and if this affected the main user's application.As a result, the caregiver was not notified via the linkup application of customer's glycemic status.The customer experienced hypoglycemia and loss of consciousness.This led them being taken to a hospital, where they were diagnosed with obstructive sleep apnea, reportedly resulted "brain damage" and received unspecified treatment by a healthcare professional (hcp).Hcp suspected that this might have been caused by the hypoglycemia, but they could not confirm a direct link.At the same time, they were unable to determine any other specific cause for the sleep apnea and "brain damage".There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
The reported complaint was investigated and determined that there were no issues with the customer's reported application that would have led to the complaint.The user reported specific question/concern with snoozing or dismissing of the alarms.The reported issue was investigated and attempted to replicate using similar configuration and the reported issue was unable to be replicated and the system functioned as intended.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRELINKUP
• Common Device Name: FLASH GLUCOSE MONITORING SYSTEM
• 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: 19570435
• Report Number: 2954323-2024-21502
• Device Sequence Number: 14493194
• Product Code: PJT
• UDI-Device Identifier: 00357599824006
• UDI-Public: 00357599824006
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 08/05/2024

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: 06/05/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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