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 Code	Loss of consciousness (2418)
Date of Event	11/20/2024
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 galaxy s10 phone with android operating system version 12.The low glucose alarm did not sound, and the customer was not alerted to changes in glucose levels.As a result, the customer experienced a loss of consciousness, which led to a fall and head injury.This resulted in a cut/tear in the skin on their head.The customer was seen at a hospital where they underwent a head ct scan, lung ultrasound, and complete morphology.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
The customer reported issues with missing low alarms.The application was downloaded, and a known good sensor was scanned using approved test fixture.¿low glucose alarm' feature in the application was enabled and the threshold was set.Alarms functioned as intended.Replication of the issue was attempted using a similar configurations.Despite a comprehensive investigation, the reported issue could not be replicated and the system functioned as intended under the tested conditions.Potential causes based on the customer¿s reported application and device history were also examined, but no issues were identified during replication that could have led to the reported issue.Therefore, the issue is not confirmed.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.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 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: 20832980
• Report Number: 2954323-2024-47323
• Device Sequence Number: 8729832
• Product Code: PZE
• UDI-Device Identifier: 00357599000042
• UDI-Public: 00357599000042
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 12/03/2024

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: 71732-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• 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