MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION Alinity I Free T4 Reagent Kit; Radioimmunoassay, free thyroxine

Catalog Number	07P70-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a.1 patient identifier reached character limit, the full 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.
Event or Problem Description
The customer observed falsely elevated alinity i free t4 for a 57-year-old white female.Patient history includes: rheumatoid arthritis, fibromyalgia, ibs, asthma, type 2 diabetes, hay fever, anxiety / panic disorder and taking medications budesonide + formoterol inhaler, cetirizine, fexofenidine, folic acid, hyoscine butylbromide, ibuprofen, leflunomide, methotrexate, omeprazole, paracetamol, prednisolone, salbutamol, and sertraline.The following results were provided (reference range 9.0-19.1 pmol/l): on (b)(6) 2026, sid (b)(6), initial free t4 result= 26.10 pmol/l; repeat results= 18.54 pmol/l, 15.95 pmol/l; (b)(6) 2026, repeat results= 12.31 pmol/l, 11.32 pmol/l additional results provided: pt result= 9.6 (reference range 9.7-12.0), inr result= 0.5, aptt result= 22.9.There was no impact to patient management reported.

• Brand Name: Alinity I Free T4 Reagent Kit
• 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: 25400385
• Report Number: 3005094123-2026-00267
• Device Sequence Number: 13446480
• Product Code: CEC
• UDI-Device Identifier: 00380740121822
• 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): 09/15/2026

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: 06/30/2026
• Device Catalogue Number: 07P70-30
• Device Lot Number: 78042UD00
• 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: 05/27/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• 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
• Usage of Device: N
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Race: White