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

Catalog Number	07K65-29
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
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 a falsely depressed architect free t4 for one patient that was not reported out of the laboratory.The following results were provided (reference range ft4 0.70-1.48 ng/dl): sid (b)(6), (b)(6) 2024, initial ft4 result <0.40 ng/dl; (b)(6)2024, repeat ft4 result= 0.85 ng/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
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 performance testing was completed which indicates the product is performing as expected.The 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 a falsely depressed architect free t4 for one patient that was not reported out of the laboratory.The following results were provided (reference range ft4 0.70-1.48 ng/dl): sid (b)(6), (b)(6)2024, initial ft4 result <0.40 ng/dl; (b)(6)2024, repeat ft4 result= 0.85 ng/dl.There was no impact to patient management 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: 21170584
• Report Number: 3005094123-2025-00021
• Device Sequence Number: 4273246
• Product Code: CEC
• UDI-Device Identifier: 00380740119799
• UDI-Public: (01)00380740119799(17)250314(10)63085UD00
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 02/19/2025

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: 12/31/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/19/2025
• 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 I1SR INTEG REFRB-ME, 01L87-84, (B)(6); ARC I1SR INTEG REFRB-ME, 01L87-84, (B)(6)
• Patient Sex: Unknown