MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT FREE T4; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number	07K65-29
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated architect free t4 results for one patient.The following results were provided (expected value = 0.70 - 1.48 ng/dl): free t4 1.50 ng/dl, repeated 1.10 / 1.12 / 1.16 ng/dl.Other results provided: tsh: 1.5784 uiu/ml (expected value = 0.35 - 4.94 iu/ml) free t3 : 3.05 pg/ml (expected value = 1.58-3.91 pg/ml).No impact to patient management was reported.
Additional Manufacturer Narrative
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 architect free t4 results for one patient.The following results were provided (expected value = 0.70 - 1.48 ng/dl): free t4 1.50 ng/dl, repeated 1.10 / 1.12 / 1.16 ng/dl.Other results provided: tsh: 1.5784 uiu/ml (expected value = 0.35 - 4.94 iu/ml) free t3: 3.05 pg/ml (expected value = 1.58-3.91 pg/ml).No impact to patient management was 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, and device history record review.Data and information provided by the customer were reviewed and support the complaint issue.Return testing was not completed as returns were not available.Review of tracking and trending data for the architect free t4 assay did identify an increase in complaints.However, an increase in complaint activity was not identified for the reagent lot.Device history review did not identify issues associated with the customer¿s observation.Accuracy testing was completed with a retained kit of the complaint lot.All validity and acceptance criteria were met during completion of the protocol, demonstrating that the lot is performing as expected.Labeling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency of the architect free t4 reagent was identified.

• Brand Name: ARCHITECT FREE T4
• 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: 22568211
• Report Number: 3005094123-2025-00366
• Device Sequence Number: 13073385
• Product Code: CEC
• UDI-Device Identifier: 00380740119799
• UDI-Public: (01)00380740119799(17)251210(10)72001UD00
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 08/25/2025

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: 12/10/2025
• Device Catalogue Number: 07K65-29
• Device Lot Number: 72001UD00
• 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: 07/04/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• 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: ARC I1000SR INTGR, 01L86-40, (B)(6); ARC I1000SR INTGR, 01L86-40, (B)(6)
• Patient Sex: Unknown