MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT FREE T4 REAGENT KIT; 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	01/16/2025
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.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 for multiple samples.This was identified after a positive shift in quality controls was seen.The following example data was provided: sid (b)(6): initial result = 24.59, repeat = 15.93, repeats after recalibration = 15.06 and 16.17 no impact to patient management was reported.
Additional Manufacturer Narrative
Section d4 expiration date was updated from 05/14/2025 to 03/14/2025 section d4 primary udi number was updated from (b)(4).Return testing was not completed as returns were not available.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 complaints for list number 07k65, however, an increase in complaint activity for lot 63085ud00 was not identified.Additionally, in-house accuracy testing was completed with a retained kit of reagent lot 63085ud00.All validity and acceptance criteria were met during completion of the protocol, demonstrating that the lot is performing as expected.Device history record review did not identify any nonconformances, potential nonconformances or deviations associated with lot number 63085ud00 and the complaint issue.Labeling was reviewed and adequately addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect free t4 for lot 63085ud00 was identified.
Event or Problem Description
The customer observed falsely elevated architect free t4 results for multiple samples.This was identified after a positive shift in quality controls was seen.The following example data was provided: sid (b)(6): initial result = 24.59, repeat = 15.93, repeats after recalibration = 15.06 and 16.17 no impact to patient management was reported.
Additional Manufacturer Narrative
A further review, a typographical error was identified in section d4 primary udi number.Section d4 primary udi number was corrected from (b)(4).To (b)(4).
Event or Problem Description
The customer observed falsely elevated architect free t4 results for multiple samples.This was identified after a positive shift in quality controls was seen.The following example data was provided: sid (b)(6): initial result = 24.59, repeat = 15.93, repeats after recalibration = 15.06 and 16.17 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: 21279914
• Report Number: 3005094123-2025-00048
• Device Sequence Number: 7909368
• Product Code: CEC
• UDI-Device Identifier: 00380740119799
• UDI-Public: (01)00380740119799(17)250314(10)63085UD00
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 03/14/2025

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: 03/14/2025
• Device Catalogue Number: 07K65-29
• Device Lot Number: 63085UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 02/19/2025; 03/07/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 02/20/2025; 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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, I1SR51492; ARC I1000SR MOD, 01L86-01, I1SR51492; ARC I1000SR MOD, 01L86-01, I1SR51492
• Patient Sex: Unknown