MAUDE Adverse Event Report: Abbott Diabetes Care Ltd FreeStyle Libre 3; Continuous Glucose Monitoring System

Model Number	78754-01
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer initially reported no power with the abbott diabetes care device.The product was returned and investigated for not powering on, however during investigation reader was observed getting hot while charging.This report is being submitted due to the additional issue observed during returned product investigation.There no was no report of fire, smoke, explosion or shock.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
Product has been returned and is currently undergoing investigation process.A follow-up report will be submitted upon completion of investigation activities or if additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FreeStyle Libre 3
• Common Device Name: Continuous Glucose Monitoring System
• Manufacturer (Section D): Abbott Diabetes Care Ltd; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: melissa pieplow ; 1360 south loop road; alameda, CA 94502--700 ; +1(510)384-5975
• MDR Report Key: 50475131
• Report Number: 2954323-2026-294807
• Device Sequence Number: 13305327
• Product Code: QBJ
• UDI-Device Identifier: 00357599842017
• UDI-Public: (01)00357599842017(10)01G315D
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223435
• 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): 08/27/2026

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: 78754-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2025
• 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
• Patient Sex: Unknown