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	12/19/2025
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.A1 patient idendifer: complete sample id is (b)(6).
Event or Problem Description
The customer reported a falsely elevated alinity i free t4 (ft4) result for a female patient in her 30s with a medical history of grave¿s disease and is currently on thyradin (thyroid hormone replacement medication) generated on the alinity i processing module.The following data was provided: previous ft4 result (tested in (b)(6) 2024) = 1.30 ng/dl.On (b)(6) 2025, sid (b)(6): initial ft4 result = 2.16 ng/dl (due to the previous value, the customer retested the sample) repeat ft4 results: first repeat (sid 84) = 1.41 ng/dl; second repeat (sid 84-2) = 1.35 ng/dl there was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, review of the device history record, in-house testing of a retained kit of the complaint lot, and field data review.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Review of tracking and trending data identified an increase in complaints for the alinity i free t4 assay as well as an increase in complaint activity for reagent lot 78042ud0.However, testing was performed utilizing retained kits of the complaint lot and noted that all testing passed, indicating the reagent lots are performing as expected.Device history record review did not identify any nonconformances or deviations associated with lot 78042ud0 and the complaint issue.The overall performance of alinity i free t4 reagents in the field was reviewed using data gathered from customers worldwide.The median population result for the complaint lot 78042ud00 is within established limits, indicating that the lot is performing acceptably in the field.Labeling was reviewed and adequately addresses the customer's issue.Based on the investigation, no systemic issue or product deficiency of the alinity i free t4 reagent lot 78042ud0 was identified.
Event or Problem Description
The customer reported a falsely elevated alinity i free t4 (ft4) result for a female patient in her 30s with a medical history of grave¿s disease and is currently on thyradin (thyroid hormone replacement medication) generated on the alinity i processing module.The following data was provided: previous ft4 result (tested in (b)(6) 2024) = 1.30 ng/dl.On (b)(6) 2025, sid (b)(6): initial ft4 result = 2.16 ng/dl (due to the previous value, the customer retested the sample).Repeat ft4 results: first repeat (sid 84) = 1.41 ng/dl; second repeat (sid 84-2) = 1.35 ng/dl.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 ; 6122582960
• MDR Report Key: 24042854
• Report Number: 3005094123-2026-00017
• Device Sequence Number: 18778264
• Product Code: CEC
• UDI-Device Identifier: 00380740121822
• UDI-Public: (01)00380740121822(17)260630(10)78042UD00
• 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): 04/03/2026

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: 12/23/2025
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/03/2026
• 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).; ALNTY I PROCESSING MODU, 03R65-01, (B)(6).
• Patient Age: 30 YR
• Patient Sex: Female