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

Catalog Number	07K65-34
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2024
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.All available patient information has been included.No additional patient details are available.
Event or Problem Description
The customer observed falsely elevated architect free t4 results on a patient diagnosed with hypothyroidism.The following data was provided: on (b)(6) 2023.Tsh 1.65, ft3 2.41, ft4 1.42.Sid (b)(6) , on (b)(6) 2024 , initial test, repeat test, tsh 2.8109 uiu/ml, 3.5787 uiu/ml, ft3 2.84 pg/ml, 2.33 pg/ml, ft4 >5.00 ng/dl, 1.95 ng/dl.Sid (b)(6), on (b)(6) 2024, initial test, repeat test, ft4 >5.00 ng/dl, 0.96 ng/dl.Sid (b)(6), on (b)(6) 2024, initial test, repeat test, ft4 2.05 ng/dl, 1.18 ng/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and align with the complaint issue and no additional issues were identified.The ticket search by lot indicates that the reagent lot shows elevated complaint activity, however, in-house performance testing was completed which indicates the product is performing as expected.Device history review did not identify any non-conformances or deviations with the complaint list number.A review of ticket trending did not identify any related trend regarding commonalities for complaint lot number and issue.Retained analysis of architect free t4 reagent lot 56001ud00 was performed.Testing met acceptance criteria and the product is performing as expected.A review of the labelling addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect free t4 assay was identified.

• 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: 18917399
• Report Number: 3005094123-2024-00126
• Device Sequence Number: 6769913
• Product Code: CEC
• UDI-Device Identifier: 00380740119805
• UDI-Public: 00380740119805
• 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): 04/30/2024

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: 10/19/2023
• Device Catalogue Number: 07K65-34
• Device Lot Number: 56001UD00
• 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: 03/02/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• 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 I2K PROC MOD, 03M74-01, ISR55690; ARC I2K PROC MOD, 03M74-01, ISR55690
• Patient Sex: Unknown