MAUDE Adverse Event Report: Abbott Diabetes Care Inc FreeStyle Libre 2; Flash Glucose Monitoring System

Model Number	71992-01
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported an unexpected high/low glucose alarm with the adc device, in use with the application.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
At this time, product has not yet been returned.An investigation has been performed for the reported complaint information.The device history records (dhrs) for the product were reviewed and the dhrs showed the product passed all tests prior to release.The investigation included a review of the complaint information.The reported configuration is not compatible with the user's reported application.The compatibility guide is available to the customer on the product's website.As the compatibility guide is provided to the customer and incompatible configurations were used, this complaint is determined to be due to use error.Based on the investigation findings, no software malfunction or product deficiency was identified.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.If the product is returned, a physical investigation will be performed and a follow-up report submitted.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 Libre 2
• Common Device Name: Flash Glucose Monitoring 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: 50515047
• Report Number: 2954323-2026-308550
• Device Sequence Number: 15780276
• Product Code: QLG
• UDI-Device Identifier: 05021791002504
• UDI-Public: (01)05021791002504(17)2026-12-31(10)KTP013489
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K193371
• 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: 71992-01
• 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: 10/11/2025
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown