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

Model Number	78802-01
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2026
Type of Reportable Event	Malfunction

• Brand Name: FreeStyle Libre
• Common Device Name: Flash 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: 50141491
• Report Number: 2954323-2026-186219
• Device Sequence Number: 13426079
• Product Code: QLG
• UDI-Device Identifier: 00357599000196
• UDI-Public: (01)00357599000196(17)260930(10)260207P(91)71940-01
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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): 08/05/2026

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: 78802-01
• 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: 07/11/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Female