MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number	71992-01
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	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.At this time, the product has not yet been returned for this complaint.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the libre sensor and sensor kit was reviewed and the dhrs showed the libre sensor and sensor kit met specifications prior to release to distribution.If the product is returned, a physical investigation will be performed and a follow-up report will be submitted.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A customer reported receiving erroneous glucose results from an abbott diabetes care device.The customer received sensor scan results of 61.00 mg/dl compared to readings of 191.00 mg/dl 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 1 day.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed on the sensor patch.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Sensor state 5 with event logs 3 and 4 are an indication of normal termination of the sensor without any error.Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.The passing of functionality testing is an indication that there were no issues with sensor functionality and electronics.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A customer reported receiving erroneous glucose results from an abbott diabetes care device.The customer received sensor scan results of 61.00 mg/dl compared to readings of 191.00 mg/dl 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 1 day.There was no report of death, serious injury, or mistreatment associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• Common Device Name: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda, CA 94502-7001 ; 4157205405
• MDR Report Key: 24869801
• Report Number: 2954323-2026-29264
• Device Sequence Number: 9081677
• Product Code: QLG
• UDI-Device Identifier: 00357599836009
• UDI-Public: (01)00357599836009(17)2026-03-31(10)KTP013432
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193371
• 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,Followup
• Report Date (Section B): 05/21/2026

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: 03/31/2026
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• 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