MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT FREE T4; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number	07K65-29
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely elevated architect free t4 result for one (b)(6) year old male patient with pre-existing heart failure in stable condition.The patient¿s ft4 was lower with another method.The following data was provided: (b)(6) 2025 architect results = >5.00 and >5.00 ng/dl using reagent lot 73547ud00.(b)(6) 2025 architect result = >5.00 ng/dl using reagent lot 76216ud00.(b)(6) 2025 architect result = >5.00 ng/dl using reagent lot 76216ud00.(b)(6) 2025 architect result = >5.00 ng/dl using reagent lot 76216ud00.Treatment: potassium iodide prescription starting (b)(6) 2025.Normal reference range = ft4 0.70-1.48ng/dl.(b)(6) 2025 receptor antibody, thyroglobulin antibody, tpo antibody: normal.Results of outsourced testing (1step method) ft4: 1.25 ng/dl.Additional data provided 02dec2025: reference lab results: reproducibility test: ft4 (ng/dl) 1.02.Addition of heterophile antibody blockers for ft4 did not result in a significant decrease in the measured values.No impact to patient management was reported.
Event or Problem Description
The customer observed a falsely elevated architect free t4 result for one (b)(6) year old male patient with pre-existing heart failure in stable condition.The patient¿s ft4 was lower with another method.The following data was provided: on (b)(6) 2025 architect results = >5.00 and >5.00 ng/dl using reagent lot 73547ud00, (b)(6) 2025 architect result = >5.00 ng/dl using reagent lot 76216ud00, (b)(6) 2025 architect result = >5.00 ng/dl using reagent lot 76216ud00, (b)(6) 2025 architect result = >5.00 ng/dl using reagent lot 76216ud00.Treatment: potassium iodide prescription starting (b)(6) 2025.Normal reference range = ft4 0.70-1.48ng/dl.On (b)(6) 2025 receptor antibody, thyroglobulin antibody, tpo antibody: normal.Results of outsourced testing (1step method) ft4: 1.25 ng/dl.Additional data provided (b)(6) 2025: reference lab results: reproducibility test: ft4 (ng/dl) 1.02.Addition of heterophile antibody blockers for ft4 did not result in a significant decrease in the measured values.No impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, a ticket trending review, a device history record review, and a labeling review.In addition, in-house testing of retained reagent kit was also completed.The data and information provided by the customer were reviewed and support the complaint issue.A review of tracking and trending data for the architect free t4 assay (list number 07k65) did identify an increase in complaint activity.However, an increase in complaint activity for lot 73547ud00 was not identified.Additionally, in-house performance testing was performed utilizing retained reagent kit of lot 73547ud00.All testing passed indicating the reagent lot is performing as expected.A review of the device history record did not identify any non-conformances or deviations with lot number 73547ud00 and the complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.Based on this investigation, no systemic issue or deficiency was identified with the architect free t4 reagent, lot number 73547ud00.

• Brand Name: ARCHITECT FREE T4
• Common Device Name: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23717178
• Report Number: 3005094123-2025-00618
• Device Sequence Number: 8845519
• Product Code: CEC
• UDI-Device Identifier: 00380740119799
• UDI-Public: (01)00380740119799(17)260303(10)73547UD00
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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: Health Professional
• Device Expiration Date: 03/03/2026
• Device Catalogue Number: 07K65-29
• Device Lot Number: 73547UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2K PROC MOD, 03M74-01, (B)(6); ARC I2K PROC MOD, 03M74-01, (B)(6)
• Patient Sex: Male