MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE PRECISION PRO; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	71411-70
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	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested back for investigation and the customer agreed to return the device.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.
Event or Problem Description
A healthcare professional reported a high reading from an abbott diabetes care blood glucose hospital meter.The healthcare professional reported a high blood glucose reading of 500 mg/dl compared to an abbott diabetes care blood glucose meter reading of 79 mg/dl.When plotted on a parkes error grid, the results fall in the d zone showing the difference in values to be clinically significant.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
The returned meter was investigated with a known-good retained.Visual inspection was performed on returned meter and no issues were observed.Meter powered on with button depression.Visual inspection was performed observed lcd during power up/ self-test sequence, no issues observed.Performed control solution test.All results within specification.No issues were observed with returned meter.Issue is not confirmed.A valid serial number has not been provided for freestyle strip.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that freestyle strips continue to be safe, effective, and perform as intended in the field stability data for freestyle strips was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.The available tracking and trending reports were conducted for the reported complaint and freestyle strips, no trends were identified that would indicate any product related issues.Dhrs (device history review) for the freestyle precision pro meter was reviewed and the dhrs showed the freestyle precision pro meter met specifications prior to release to distribution.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A healthcare professional reported a high reading from an abbott diabetes care blood glucose hospital meter.The healthcare professional reported a high blood glucose reading of 500 mg/dl compared to an abbott diabetes care blood glucose meter reading of 79 mg/dl.When plotted on a parkes error grid, the results fall in the d zone showing the difference in values to be clinically significant.There was no report of death, serious injury, or mistreatment associated with this event.

• Brand Name: FREESTYLE PRECISION PRO
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda 94502 7001
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda 94502-7001 ; 4157205405
• MDR Report Key: 23932994
• Report Number: 2954323-2025-52274
• Device Sequence Number: 5610121
• Product Code: NBW
• UDI-Device Identifier: 00357599807009
• UDI-Public: (01)00357599807009(10)01E009D
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140371
• 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): 02/03/2026

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: 71411-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• 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 Sex: Unknown