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

Model Number	78768-01
Medical Device Problem Codes	Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury

• 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: melissa pieplow ; 1360 south loop road; alameda, CA 94502--700 ; +1(510)384-5975
• MDR Report Key: 50891895
• Report Number: 2954323-2026-428548
• Device Sequence Number: 10712407
• Product Code: QBJ
• UDI-Device Identifier: 30357599843015
• UDI-Public: (01)30357599843015(17)2027-01-31(10)T60004298(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): 09/24/2026

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: 08/26/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2026
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Unknown