MAUDE Adverse Event Report: Abbott Diabetes Care Inc FreeStyle LibreLink; Data Management System

Model Number	71732-01
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported a missing high/low glucose alarm with the adc device.There was no indication that the customer experienced an adverse event or required intervention as a result of the reported issue.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
An investigation has been performed for the reported complaint information.The investigation included a review of the complaint information and replication of user reported issue using a known good sensor and device of similar configuration.Functionality testing of the user reported alarm feature was performed to evaluate application performance to ensure the application is functioning as intended.Based on the investigation findings, no software malfunction or product deficiency was identified; therefore, the issue is not confirmed.It is not possible to determine the probable cause of this event.There are mitigations in place to reduce and prevent issues such as disconnected, faulty or damaged components or misuse of the device.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.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.This complaint was reviewed and is being submitted as it has been reassessed as reportable as the result of retrospective review associated with a capa.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 CA 94502 -700
• Manufacturer Contact: melissa pieplow ; 1360 south loop road; alameda, CA 94502--700 ; +1(510)384-5975
• MDR Report Key: 50515084
• Report Number: 2954323-2026-308567
• Device Sequence Number: 10675235
• Product Code: PZE
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 08/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 71732-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 08/31/2026
• 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
• Patient Sex: Unknown