MAUDE Adverse Event Report: Abbott Ireland Diagnostics Division ARCHITECT Free T4; Radioimmunoassay, free thyroxine

Catalog Number	07K65-39
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated architect free t4 results generated on the architect i2000sr processing module for multiple samples.The following results were provided: (customer provided free t4 reference range: 10 - 24 pmol/l): (b)(6) 2026, sid (b)(6), initial result = 35.3 pmol/l, repeat result = 18.7 pmol/l; (b)(6) 2026, sid (b)(6), initial result = 27.7 pmol/l, repeat result = 14.9 pmol/l; (b)(6) 2026, sid (b)(6), initial result = 28.3 pmol/l, repeat result = 21.8 pmol/l; (b)(6) 2026, sid (b)(6), initial result = 30.4 pmol/l, repeat result = 22.2 pmol/l; sid (b)(6), initial result = >64.35 pmol/l, repeat result = 22.6 pmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
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.All available patient information was included.Additional patient details are not available.

• 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: 25593903
• Report Number: 3005094123-2026-00305
• Device Sequence Number: 17567881
• Product Code: CEC
• UDI-Device Identifier: 00380740119812
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2026

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: 07K65-39
• Device Lot Number: 84182UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2026
• Supplement Date Received by Manufacturer: 06/26/2026; 09/24/2026
• Initial Report FDA Received Date: 06/23/2026
• Supplement Report FDA Received Date: 07/14/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2026
• 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
• Usage of Device: N
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2000SR INST, 03M74-02, ISR54191.
• Patient Sex: Unknown