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	12/10/2025
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.Section a1 - patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a falsely elevated architect free t4 result for a 47-year-old female patient.The following data was provided (customer¿s reference range is 0.700-1.480 ng/dl) sample id (b)(6) initial result was >5.00, repeat result was 1.19 ng/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for a falsely elevated architect free t4 result included a search for similar complaints, the review of complaint text, trending data, labeling, and device history records.A review of tracking and trending did identify an increase in complaints for list number 07k65, however, no trends were identified for the complaint lot.Using worldwide field data gathered via from customers, the performance of reagent lot 77507ud00 was evaluated and is performing similar to other reagent lots in the field, confirming there was no systemic issue.The median value of the complaint lot number is within the established limits and comparable to historical reagent lot performance.Device history record review did not identify any non-conformances, potential non-conformances, or deviations associated with the list number and the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on our investigation, no systemic issue or deficiency with the architect free t4 reagent, lot number 77507ud00, was identified.
Event or Problem Description
The customer observed a falsely elevated architect free t4 result for a 47-year-old female patient.The following data was provided (customer¿s reference range is 0.700-1.480 ng/dl) sample id (b)(6) initial result was >5.00, repeat result was 1.19 ng/dl.There was no impact to patient management 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: 23881825
• Report Number: 3005094123-2025-00661
• Device Sequence Number: 9623035
• Product Code: CEC
• UDI-Device Identifier: 00380740119799
• UDI-Public: (01)00380740119799(17)260707(10)77507UD00
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 04/02/2026

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: 07/07/2026
• Device Catalogue Number: 07K65-29
• Device Lot Number: 77507UD00
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2025
• 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 INTGR, 01L86-40, (B)(6); ARC I1000SR INTGR, 01L86-40, (B)(6)
• Patient Age: 47 YR
• Patient Sex: Female