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

Model Number	72079-01
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported their adc device is too hot to hold.There 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
Reader (b)(6) has been returned and investigated.Visual inspection has been performed and the serial number was observed to be rubbed off.No evidence of the reader being too hot to hold was observed.A built in reader test was performed and results were within specification.De-cased the returned reader and performed visual inspection of the printed circuit board assembly (pcba), no signs of damage or burn marks were observed.Liquid contamination was observed on the pcba.The returned battery was measured and results were within specification.Using a thermal camera the reader was monitored and the temperature was observed to be within specification.Power consumption was not able to be performed due to liquid contamination.The observed liquid contamination observed is the result of foreign ingress introduced to the pcba while in the hands of the customer.This contamination is not an indication of a product failure and is the result of misuse.Furthermore, the lack of hot spots on the pcba through the thermal camera is an indication the electronics of the reader were not producing excessive heat and thus is not the cause of the complaint.Therefore, this issue not confirmed to use.This complaint has been reassessed as reportable upon retrospective review associated with a capa and is being submitted with all available information.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: 50803018
• Report Number: 2954323-2026-420934
• Device Sequence Number: 10589719
• Product Code: QBJ
• UDI-Device Identifier: 00357599820008
• 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): 09/17/2026

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: 72079-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2023
• 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