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	11/28/2023
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 54 mg/dl compared to glucose values of 154 mg/dl respectively obtained on the comparison device, 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 4 days.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
The reported device was returned and investigated.The investigation included a review of the complaint information, available device data, and an inspection of the returned product.A visual inspection of the device was performed to assess for evidence of physical abnormalities.Functionality testing was performed to evaluate device performance to ensure device is functioning as intended.The device history records (dhrs) for the product were reviewed and the dhrs showed the product passed all tests prior to release.Based on the investigation findings, no device malfunction or product deficiency was identified; therefore, the issue is not confirmed.This complaint was reviewed and is being submitted as it has been reassessed as reportable as the result of retrospective review associated with a capa.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: 50814879
• Report Number: 2954323-2026-422267
• Device Sequence Number: 10712930
• Product Code: QBJ
• UDI-Device Identifier: 30357599819003
• UDI-Public: (01)30357599819003(17)2024-01-31(10)T60001090(91)72080-01
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/18/2026

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 Expiration Date: 01/31/2024
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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 Age: 34 YR
• Patient Sex: Male