MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I FREE T4 REAGENT KIT; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number	07P70-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
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.
Event or Problem Description
The customer reported falsely decreased alinity i free t4 generated from alinity i processing module and provided the following data: patient 1: on (b)(6) 2026, sid (b)(6) free t4 result was 21.88.The patient's physician questioned this result and when the sample was repeated the result was 21.88.(alinity reference range is: 9.01-19.05 pmol/l.).When tested on the snibe platform, the resutls were 33.5 and 32.5 (snibe reference range: 11.58-22.52 pmol/l).The physician considers the ft4 result on the snibe analyzer to be more consistent with the patient's clinical condition.Patient information: female; 30 years old.Diagnostics: bronchial asthma attack/hyperthyroidism; the patient is not taking any medication.Additional laboratory data provided: tsh < 0.0083 uiu/ml patient 2: on (b)(6) 2026, sid (b)(6) free t4 result was 14.68.The patient's physician questioned this result and when the sample was repeated the result was 14.81.(alinity reference range is: 9.01-19.05 pmol/l.).When tested on the snibe platform, the result was 25.5 (snibe reference range: 11.58-22.52 pmol/l).The physician considers the ft4 result on the snibe analyzer to be more consistent with the patient's clinical condition.Patient information: female; 23 years old.Diagnostics: hyperthyroidism.Additional laboratory data provided: ft3: 4.16 pmol/l; tsh: 0.0684 uiu/ml there was no reported impact to patient management.

• 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: 24796145
• Report Number: 3005094123-2026-00164
• Device Sequence Number: 13438509
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: (01)00380740121815(17)260421(10)75641UD00
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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): 06/09/2026

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: 04/21/2026
• Device Catalogue Number: 07P70-20
• Device Lot Number: 75641UD00
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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