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	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated architect free t4 results for a 30-year-old female patient.The following data was provided (customer¿s normal range is 0.70-1.48 ng/dl): sample id 300178100007 initial result, on 30jul2026, was 1.64, repeat results were 1.43, 1.47, and 1.50 ng/dl.Additional results were provided: free t3 initial result was 2.47, repeat results were 2.34, 2.39, and 2.41 pg/ml; tsh initial result was 29.74, repeat results were 38.76, 39.09, and 38.74 uiu/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
Section a patient identifier, reached maximum character limit.The complete id is (b)(6).Section a patient information: refer to section b5 for complete patient information.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

• 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 ; +49()6122582960
• MDR Report Key: 50280800
• Report Number: 3005094123-2026-00402
• Device Sequence Number: 13356718
• Product Code: CEC
• UDI-Device Identifier: 00380740119799
• UDI-Public: (01)00380740119799(17)270202(10)84185UD00
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 09/10/2026

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 Catalogue Number: 07K65-29
• Device Lot Number: 84185UD00
• 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: 07/29/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 08/17/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2026
• 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, ISR64222
• Patient Age: 30 YR
• Patient Sex: Female