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	02/10/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A health care professional reported receiving erroneous glucose results from an hospital abbott diabetes care blood glucose device.The health care professional reported a blood glucose results of 400 mg/dl compared to a reading of 125 mg/dl respectively obtained on an abbott diabetes care blood glucose devie and the results, when plotted on a parkes error grid, fall into the c 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 test strips and a known-good retained battery.Visual inspection has been performed on the returned meter, strip port module and no issues were observed.Retained batteries were installed.Meter powered on with button depression.No issues were observed with the lcd during power up and self-test sequence.Control solution testing has been performed and all results were within range specification.No malfunction or product deficiency was identified.Therefore, issue is not confirmed.At this time freestyle strips has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specifications.A valid lot number was not provided for the strip.The dhrs (device history review) for the freestyle precision pro meter and strip port module were reviewed and the dhrs showed the freestyle precision pro meter and strip port module passed all tests prior to release.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 led 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.If partial product is returned, a physical investigation will be performed per adc's established processes and procedures and a report will be submitted upon completion of investigation.This also serves as a correction report.Section h4 (device mfg date) was incorrectly updated in the previous report.Correction has been made.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A health care professional reported receiving erroneous glucose results from an hospital abbott diabetes care blood glucose device.The health care professional reported a blood glucose results of 400 mg/dl compared to a reading of 125 mg/dl respectively obtained on an abbott diabetes care blood glucose devie and the results, when plotted on a parkes error grid, fall into the c 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 CA 94502 7001
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda, CA 94502-7001 ; 4157205405
• MDR Report Key: 21540233
• Report Number: 2954323-2025-08249
• Device Sequence Number: 7133877
• Product Code: NBW
• UDI-Device Identifier: 00357599807009
• UDI-Public: (01)00357599807009(10)01A227D
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K132511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2025

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: Health Professional
• Device Model Number: 71411-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown