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

Catalog Number	07K65-34
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated architect free t4 results generated on the architect i2000sr processing module for three patient samples.The following information was provided: (customer provided reference range 0.78-1.48 ng/dl).On (b)(6) 2024, sid (b)(6), initial result = 1.50 ng/dl, repeat result = 1.30ng/dl.Additional lab result provided: tsh result = 2.Tsh result = 15 uiu/ml, no repeat result provided.On (b)(6) 2024, sid (b)(6), initial result = 1.59 ng/dl, repeat result = 1.26ng/dl additional lab result provided: tsh result = 2.39 uiu/ml, no repeat result provided.On (b)(6) 2024, sid (b)(6), initial result = 1.59 ng/dl, repeat result = 1.19ng/dl.Additional lab result provided: tsh result =1.39 uiu/ml, no repeat result provided no impact to patient management was reported.
Additional Manufacturer Narrative
Section a1 patient identifier complete information: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated architect free t4 results 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.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.Additionally, a slight increase in complaint activity was identified for reagent lot 63114ud00.However, in house accuracy testing was performed utilizing retained kit of lot 63114ud00.All validity and acceptance criteria were met, demonstrating that the lot is performing as expected.Device history review did not identify any nonconformances, potential nonconformances, or deviations associated with the likely cause list number.Labeling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency of the architect free t4 reagent lot 63114ud00 was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated architect free t4 results generated on the architect i2000sr processing module for three patient samples.The following information was provided: (customer provided reference range 0.78-1.48 ng/dl).(b)(6) 2024 sid (b)(6) initial result = 1.50 ng/dl, repeat result = 1.30ng/dl.Additional lab result provided: tsh result = 2.Tsh result = 15 uiu/ml, no repeat result provided.(b)(6) 2024 sid (b)(6) initial result = 1.59 ng/dl, repeat result = 1.26ng/dl.Additional lab result provided: tsh result = 2.39 uiu/ml, no repeat result provided (b)(6) 2024sid (b)(6) initial result = 1.59 ng/dl, repeat result = 1.19ng/dl.Additional lab result provided: tsh result =1.39 uiu/ml, no repeat result provided.No impact to patient management was reported.

• Brand Name: ARCHITECT 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: 21276864
• Report Number: 3005094123-2025-00045
• Device Sequence Number: 18280618
• Product Code: CEC
• UDI-Device Identifier: 00380740119805
• UDI-Public: (01)00380740119805(17)250422(10)63114UD00
• 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): 02/25/2025

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: 04/22/2025
• Device Catalogue Number: 07K65-34
• Device Lot Number: 63114UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• 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 I2K PROC MOD, 03M74-01, (B)(6).; ARC I2K PROC MOD, 03M74-01, (B)(6).
• Patient Sex: Unknown