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

Catalog Number	07K65-34
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a falsely decreased architect free t4 result generated by the architect i2000sr processing module for a 37-year-old male patient.The result was inconsistent with another sample collected on the same day.The following data was provided: (b)(6) 2025 at 12:02 sid: (b)(6) result = 0.84 ng/dl.(b)(6) 2025 at 13:00 sid: (b)(6) result = 0.67 ng/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
Section a1 - patient identifier: complete sample id is (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported a falsely decreased architect free t4 result generated by the architect i2000sr processing module for a 37-year-old male patient.The result was inconsistent with another sample collected on the same day.The following data was provided: (b)(6) 2025 at 12:02 sid: (b)(6) result = 0.84 ng/dl.(b)(6) 2025 at 13:00 sid: (b)(6) result = 0.67 ng/dl no impact to patient management was reported.
Additional Manufacturer Narrative
After further evaluation, the suspect medical device was changed from architect free t4, list 07k65-34, abbott ireland diagnostics division, longford, ireland to the architect i2000sr processing module, list 03m74-97, abbott laboratories, irving, texas, usa.Mdr number 3016438761-2025-00515 has been submitted and all further information will be documented under that mdr number.

• 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: 22505467
• Report Number: 3005094123-2025-00356
• Device Sequence Number: 9246998
• Product Code: CEC
• UDI-Device Identifier: 00380740119805
• UDI-Public: (01)00380740119805(17)251010(10)69104UD00
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K173122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 10/10/2025
• Device Catalogue Number: 07K65-34
• Device Lot Number: 69104UD00
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• 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 I2SR REFURB-SEKAT, 03M74-97, (B)(6).; ARC I2SR REFURB-SEKAT, 03M74-97, (B)(6).
• Patient Age: 37 YR
• Patient Sex: Male