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

Model Number	72081-01
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	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported receiving erroneous glucose results from an abbott diabetes care device.The customer received sensor scan results of 2.50 mmol/l, 2.90 mmol/l compared to readings of 8.30 mmol/l, 8.70 mmol/l respectively obtained on a meter and the results, when plotted on a parkes error grid, fall into the c zone, showing the difference in values to be clinically significant.The length of sensor wear was 5 days.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
The product has been requested back for investigation.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: 50898174
• Report Number: 2954323-2026-429130
• Device Sequence Number: 10711775
• Product Code: QBJ
• UDI-Device Identifier: 00357599818005
• UDI-Public: (01)00357599818005(17)261231(10)1270066
• 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): 09/25/2026

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: 72081-01
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/25/2026
• 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: Unknown