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

Catalog Number	07K65-39
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier = sid= (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 observed falsely elevated architect free t4 (ft4) results on multiple architect processing module for multiple patients.The patients were in the hospital due to heart disease.The result provided were: on (b)(6) 2024 first patient sid (b)(6) ft4 initial= 1.68 ng/dl /repeated on architect (b)(6) =0.86 and 0.83 ng/dl on (b)(6) 2024 second patient sid (b)(6) ft4 initial: 5.00 ng/dl /repeated on architect (b)(6) =0.97 and 0.95 ng/dl the customer stated the patients underwent for cardiac catheterization due to the patient's current condition.There was no reported impact to patient management.
Event or Problem Description
The customer observed falsely elevated architect free t4 (ft4) results on multiple architect processing module for multiple patients.The patients were in the hospital due to heart disease.The result provided were: on (b)(6) 2024 ,first patient sid (b)(6) , ft4 initial= 1.68 ng/dl /repeated on architect (b)(6) =0.86 and 0.83 ng/dl.On (b)(6) 2024 ,second patient sid (b)(6), ft4 initial=>5.00 ng/dl /repeated on architect isr62760=0.97 and 0.95 ng/dl.The customer stated the patients underwent for cardiac catheterization due to the patient's current condition.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and in-house testing for architect free t4 reagent lot: 56001ud01.There was an increase in complaint activity lot 56001ud01 and 56001ud, however, no related trends were identified.Additionally, in-house performance testing was completed which indicates the product is performing as expected on lot number 56001ud00.Return testing was not completed as returns were not available.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.A review of labeling concluded that the issue is sufficiently addressed.A manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Based on the investigation no product deficiency was identified for the architect free t4 reagent lot number 56001ud01.

• 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: 19351244
• Report Number: 3005094123-2024-00265
• Device Sequence Number: 7110132
• Product Code: CEC
• UDI-Device Identifier: 00380740119812
• UDI-Public: (01)00380740119812(17)240926(10)56001UD01
• 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): 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): 06/20/2024

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: 09/26/2024
• Device Catalogue Number: 07K65-39
• Device Lot Number: 56001UD01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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
• Usage of Device: Unknown
• 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