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	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6) (total of 2 patients).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated patient results over the past year when using the architect free t4 assay.The customer stated a doctor pointed out that while the free t4 values are high in many samples, the free t3 and tsh results are within the normal range.The customer provided 2 cases that deviated across the reference range.The following data provided (reference range for free t4: 0.70 ¿ 1.48 ng/dl): sid (b)(6): initial free t4 result = 1.334658 ng/dl; repeat result = 1.588634 ng/dl (questioning the higher repeat result).Sid (b)(6): initial free t4 result = 1.48657 ng/dl; repeat result = 1.023434 ng/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, in house testing, and field data review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.An increase in complaints has been observed for lot 61281ud00, however, in-house performance testing was completed which indicates the product is performing as expected.A review of the device history record did not identify any non-conformances or deviations related to the complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified for architect free t4 reagent lot 61281ud00.
Event or Problem Description
The customer reported falsely elevated patient results over the past year when using the architect free t4 assay.The customer stated a doctor pointed out that while the free t4 values are high in many samples, the free t3 and tsh results are within the normal range.The customer provided 2 cases that deviated across the reference range.The following data provided (reference range for free t4: 0.70 ¿ 1.48 ng/dl): sid (b)(6) : initial free t4 result = 1.334658 ng/dl; repeat result = 1.588634 ng/dl (questioning the higher repeat result).Sid (b)(6) : initial free t4 result = 1.48657 ng/dl; repeat result = 1.023434 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: 20080535
• Report Number: 3005094123-2024-00450
• Device Sequence Number: 7652491
• Product Code: CEC
• UDI-Device Identifier: 00380740119799
• UDI-Public: (01)00380740119799(17)250219(10)61281UD00
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/08/2024

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: 02/19/2025
• Device Catalogue Number: 07K65-29
• Device Lot Number: 61281UD00
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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 I2K PROC MOD, 03M74-01, (B)(6) ; ARC I2K PROC MOD, 03M74-01, (B)(6)
• Patient Sex: Unknown