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

Catalog Number	07K65-34
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
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.Complete information for section a patient identifier and age/gender: patient 1 (15-year-old female) with sid (b)(6).Patient 2 sid, age, gender not provided.
Event or Problem Description
The customer reported falsely elevated architect free t4 results generated by the architect i2000sr processing module for two patients.Upon repeat testing, lower results were obtained.The following data was provided: patient 1 (15-year-old female): sid (b)(6): initial architect free t4 result = >5.0 ng/dl repeat result = 1.24 ng/dl.Patient 2: initial architect free t4 result = 2.40 ng/dl repeat result = 0.85 ng/dl.Per the architect free t4 package insert, the normal range is 0.70 ng/dl to 1.48 ng/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
A complaint investigation was conducted for the architect free t4 reagent lot 70403ud03.A review of tracking and trending did identify an increase in complaints for list number 07k65, however, no trends were identified for lot 70403ud03.Device history review did not identify issues associated with the customer¿s observation.The overall performance of architect free t4 reagent was reviewed using worldwide field data.The median population result for the complaint lot is within established limits, indicating that the lot is performing acceptably in the field.Labeling was reviewed which adequately addresses the current issue.Based on our investigation, no systemic issue or deficiency was identified with the architect free t4 reagent lot 70403ud03.
Event or Problem Description
The customer reported falsely elevated architect free t4 results generated by the architect i2000sr processing module for two patients.Upon repeat testing, lower results were obtained.The following data was provided: patient 1 (15-year-old female): sid (b)(6): initial architect free t4 result = >5.0 ng/dl repeat result = 1.24 ng/dl.Patient 2: initial architect free t4 result = 2.40 ng/dl repeat result = 0.85 ng/dl.Per the architect free t4 package insert, the normal range is 0.70 ng/dl to 1.48 ng/dl.No impact to patient management was reported.

• 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: 23583872
• Report Number: 3005094123-2025-00582
• Device Sequence Number: 9398800
• Product Code: CEC
• UDI-Device Identifier: 00380740119805
• UDI-Public: (01)00380740119805(17)251118(10)70403UD00
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K173122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: 11/18/2025
• Device Catalogue Number: 07K65-34
• Device Lot Number: 70403UD00
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2024
• 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 I2SR REFURB-BRAZIL, 03M74-56, (B)(6); ARC I2SR REFURB-BRAZIL, 03M74-56, (B)(6)
• Patient Sex: Unknown