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	08/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being filed on an international product, list number 7p70 that has a similar product distributed in the us, list number 7p70, with 510k number k173122.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 depressed alinity i free t4 results for an 83-year-old female patient.The following data was provided: on (b)(6) 2025 initial free t4 (b)(6) 2025) 1.21, repeated (b)(6) 2025) 1.78.Historical results free t4 (b)(6) 2025) 1.49, (b)(6) 2025) 1.3, (b)(6) 2024) 1.57, (b)(6) 2024) 1.44, (b)(6) 2024) 1.35, (b)(6) 2024) 2.72, (b)(6) 2023) 1.97, (b)(6) 2023) 1.24 and 1.2, (b)(6) 2023) 1.34, (b)(6) 2022) 1.67 no impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.A review of tracking and trending did identify an increase in complaint activity.However, no commonalities for the complaint lot and issue were identified.In-house testing with a retained kit of reagent lot 73276ud00 was completed.Testing met acceptance criteria, and the product is performing as expected.Device history review did not identify any nonconformances, potential nonconformances or deviations associated with the complaint lot and complaint issue.Labeling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency with the alinity i free t4 assay, lot 73276ud00 was identified.
Event or Problem Description
The customer observed falsely depressed alinity i free t4 results for an 83-year-old female patient.The following data was provided: (b)(6) 2025 initial free t4 (b)(6) 2025) 1.21, repeated (b)(6) 2025) 1.78.Historical results: free t4 ((b)(6) 2025) 1.49, (b)(6) 2025) 1.3, (b)(6) 2024) 1.57, (b)(6) 2024) 1.44, (b)(6) 2024) 1.35, (b)(6) 2024) 2.72, (b)(6) 2023) 1.97, (b)(6) 2023) 1.24 and 1.2, (b)(6) 2023) 1.34, (b)(6) 2022) 1.67.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: 23179691
• Report Number: 3005094123-2025-00488
• Device Sequence Number: 21292825
• Product Code: CEC
• UDI-Device Identifier: 00380740121815
• UDI-Public: (01)00380740121815(17)260205(10)73276UD00
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/09/2025

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: 02/05/2026
• Device Catalogue Number: 07P70-20
• Device Lot Number: 73276UD00
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Age: 83 YR
• Patient Sex: Female