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

Model Number	71732-01
Medical Device Problem Codes	Device Alarm System (1012); Application Program Problem (2880)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418); Diaphoresis (2452); Sleepiness/Drowsiness/Somnolence (4850)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An alarm issue was reported with the abbott diabetes care (adc) device in use with samsung a54 with android operating system version 14.A caregiver reported receiving a signal loss and was not alerted of changes in glucose level.As a result, the customer experienced sweating, "feeling sleepy and couldn't remember anything", loss of consciousness, and was unable to self-treat.The caregiver called a healthcare professional, who advised them to provide the customer "a can of coke, jellybabies (sweets), and two pieces of bread and butter" as treatment, which the caregiver did.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
Software investigation: an investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The customer experienced signal loss with freestyle librelink application.Per the compatibility guide, use of the samsung galaxy a54 is incompatible with the freestyle librelink application.This guide is available to the user on the websites where the product is launched.The most probable root causes associated with this failure mode are software/data corruption or misuse.However, mitigations are in place to reduce and prevent such issues.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.Section d.Suspected medical device and g4 - pma/510(k)# has been populated for the freestyle librelink android application as this report concerns a united kingdom customer.This is same/similar to us freestyle libre 2 android application, model number 71857-01.The device manufacturing date does not apply.The date entered in section h4 is the date abbott diabetes care became aware of the event.Sensor investigation: the product has been requested back for investigation and the customer agreed to return the device; however, at this time product has not yet been received.An investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the product were reviewed and the dhrs showed the product passed all tests prior to release.The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.If product is returned, a physical investigation will be performed per adc's established processes and procedures and a report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.

• 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: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 21273973
• Report Number: 2954323-2025-03685
• Device Sequence Number: 15473796
• Product Code: PZE
• UDI-Device Identifier: 00357599000042
• UDI-Public: 00357599000042
• 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
• Report Date (Section B): 01/30/2025

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: 01/23/2025
• Initial Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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