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

Model Number	71411-70
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
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 health care professional reported erratic readings on an abbott diabetes care device.Customer reported receiving readings of 23 mg/dl and 119 mg/dl within 10 minutes.The results when plotted on a parkes error grid fell 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 and strip port module , 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.An extended investigation was also performed for the reported complaint and there was no indication that the product did not meet specification.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 met specifications prior to release to distribution.Clinical data was reviewed and confirmed that the freestyle strip continue to be safe, effective, and perform as intended in the field.Stability data for the freestyle strip was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and the freestyle strip, no trends were identified that would indicate any product related issues.Upon extended investigation, it was determined that the serial number provided by the customer ((b)(6) ) and previously reported to the fda was not a valid serial number.Therefore, section d4 was updated to unk.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A health care professional reported erratic readings on an abbott diabetes care device.Customer reported receiving readings of 23 mg/dl and 119 mg/dl within 10 minutes.The results when plotted on a parkes error grid fell 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: 22980923
• Report Number: 2954323-2025-35818
• Device Sequence Number: 9549260
• Product Code: NBW
• UDI-Device Identifier: 00357599808006
• UDI-Public: (01)00357599808006(10)02D203D
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 12/17/2025

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: Lay User/Patient
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2023
• 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