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	05/01/2026
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.Section a patient information: refer to section b5 for complete patient information.All available patient information was provided, no additional patient information was available.
Event or Problem Description
The customer reported a falsely elevated alinity i free t4 result for two patients.The results were not reported out.The samples were centrifuged and repeated with lower results.The following data was provided: sid (b)(6) 26 year old male patient diagnosed with decompensated dilated cardiomyopathy.Processed on (b)(6) 2026 initial result = >64.3 repeat results = 13.89 and 14.56 pmol/l.Historical result from (b)(6) 2026 = 17.37 pmol/l.The patient is on the following medications: caspofungin, zopiclone, cefazolin, morphine, mycophenolate, methylprednisolone, teicoplanin, piperacillin, tazobactam, furosemide, levetiracetam, hydralazine, nicardipine, lansoprazole, tramadol, chloramphenamine, cyclizine, naloxone, melatonin, heparin, actrapid insulin, ondansetron.Sid (b)(6) 80 year old male patient, elective angiogram for exertional angina and shortness of breath on exertion, processed on (b)(6) 2026 initial result = 20.21 repeat results = 15.26 and 15.51 pmol/l the patient is on the following medications: clopidogrel, budesonide + formoterol inhaler, darbepoetin alfa sc, nitrates sublingual, hydroxocobalamin im, aspirin, levothyroxine, ramipril, simvastatin.Reference range 9-19.11 pmol/l no impact to patient management was 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 ; 6122582960
• MDR Report Key: 25150768
• Report Number: 3005094123-2026-00222
• Device Sequence Number: 9212792
• Product Code: CEC
• UDI-Device Identifier: 00380740121822
• UDI-Public: (01)00380740121822(17)260630(10)78042UD00
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 06/05/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 06/05/2026
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Sex: Unknown