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	07/11/2025
Type of Reportable Event	Malfunction
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 elevated architect free t4 result generated by the architect i1000sr processing module for a 56-year-old female patient, which was questioned by the physician.The same sample was repeated, and a normal result was obtained.The following data was provided: customer¿s reference range: 0.7 to 1.48 ng/dl.Sid (b)(6): on (b)(6) 2025 initial result = 3.59 ng/dl.On (b)(6) 2025 repeat result = 1.13 ng/dl.Result from another lab (architect platform) = 1.13 ng/dl.No impact to patient management was reported.
Event or Problem Description
The customer reported a falsely elevated architect free t4 result generated by the architect i1000sr processing module for a 56-year-old female patient, which was questioned by the physician.The same sample was repeated, and a normal result was obtained.The following data was provided: customer¿s reference range: 0.7 to 1.48 ng/dl.Sid (b)(6): (b)(6) 2025 initial result = 3.59 ng/dl, (b)(6) 2025 repeat result = 1.13 ng/dl, result from another lab (architect platform) = 1.13 ng/dl, no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, a ticket trending review, a device history record review, and a labeling review.In addition, in-house testing of retained reagent kit was also completed.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.A review of tracking and trending data for the architect free t4 assay (list number 07k65) did identify an increase in complaints.However, an increase in complaint activity for lot 71906ud00 was not identified.Additionally, in-house performance testing was performed utilizing retained reagent kit of lot 71906ud00.All testing passed indicating the reagent lot is performing as expected.A review of the device history record did not identify any non-conformances or deviations with lot number 71906ud00 and the complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.Based on this investigation, no systemic issue or deficiency was identified with the architect free t4 reagent, lot number 71906ud00.

• 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: 22687419
• Report Number: 3005094123-2025-00378
• Device Sequence Number: 18533272
• Product Code: CEC
• UDI-Device Identifier: 00380740119799
• UDI-Public: (01)00380740119799(17)251030(10)71906UD00
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 08/25/2025

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: 10/30/2025
• Device Catalogue Number: 07K65-29
• Device Lot Number: 71906UD00
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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 INTGR, 01L86-40, (B)(6); ARC I1000SR INTGR, 01L86-40, (B)(6)
• Patient Age: 56 YR
• Patient Sex: Female