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

Model Number	78768-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Skin Infection (4544)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An adverse skin reaction was reported with wear of the abbott diabetes care (adc) device.The customer experienced symptoms described as white pus and self-treated the affected area with triple antibiotic ointment, betadine, and hydrogen peroxide.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
Physical investigation of product is not anticipated as reporter indicated device was discarded.Investigation will be performed per adc's established processes and procedures, and a report will be submitted upon completion of investigation activities.The date of event is unknown.The date entered in section b3 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 Libre 3 Plus
• Common Device Name: Continuous Glucose Monitoring System
• Manufacturer (Section D): Abbott Diabetes Care Inc; 1360 south loop road; alameda CA 94502 -700
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda, CA 94502--700 ; +1(415)720-5405
• MDR Report Key: 50111958
• Report Number: 2954323-2026-183205
• Device Sequence Number: 10760983
• Product Code: QBJ
• UDI-Device Identifier: 00357599843007
• UDI-Public: (01)00357599843007(17)2027-01-31(10)T60004319(91)78769-01
• 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): 08/02/2026

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: 78768-01
• 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: 07/03/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Unknown