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	06/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a 1.Patient identifier character limit was maxed; the full id is (b)(6).No additional patient information provided.An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false elevated architect free t4 on a patient, 78-year-old male.Sid (b)(6) generated architect free t4 of 2.29 ng/dl that repeated after centrifugation 1.20 ng/dl.Additional testing was tsh 1.27, 1.28 uiu/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, device history record review, and in house testing of a retained reagent kit lot 69900ud00.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of tracking and trending did identify an increase in complaints for list number 07k65, however, an increase in complaint activity for lot 69900ud00 was not identified.Device history review did not identify any non-conformances or deviations with the complaint lot.In-house testing was completed using panels which mimic patient samples using an in-house retained kit.All specifications were met indicating the lot is performing acceptably.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect free t4 reagent lot 69900ud00 was identified.
Event or Problem Description
The customer observed false elevated architect free t4 on a patient, 78-year-old male.Sid (b)(6) generated architect free t4 of 2.29 ng/dl that repeated after centrifugation 1.20 ng/dl.Additional testing was tsh 1.27, 1.28 uiu/ml.No impact to patient management was reported.

• 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: 22366193
• Report Number: 3005094123-2025-00331
• Device Sequence Number: 8288744
• Product Code: CEC
• UDI-Device Identifier: 00380740119799
• UDI-Public: (01)00380740119799(17)250916(10)69900UD00
• 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): 08/27/2025

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: 09/16/2025
• Device Catalogue Number: 07K65-29
• Device Lot Number: 69900UD00
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• 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 MOD, 01L86-01, I1SR65304; ARC I1000SR MOD, 01L86-01, I1SR65304
• Patient Age: 78 YR
• Patient Sex: Male