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	10/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely increased architect free t4 result for multiple patients on architect i2000sr, serial number (b)(6).The results were not reported out.The samples were repeated on other architect i2000srs, serial numbers (b)(6), with lower results.The following data was provided: sid (b)(6) initial result from (b)(6) = 1.64 repeat result from (b)(6) = 1.42 difference of 15.49%.Sid (b)(6) initial result from (b)(6) = 1.51 repeat result from (b)(6) = 1.34 difference of 12.69%.Sid (b)(6) initial result from (b)(6) = 1.62 repeat result from (b)(6) = 1.47 difference of 10.20%.Sid (b)(6) initial result from (b)(6) = 1.72 repeat result from (b)(6) = 1.47 difference of 17.01%.Sid (b)(6) initial result from (b)(6) = 1.65 repeat result from (b)(6) = 1.30 difference of 26.92%.Sid (b)(6) initial result from (b)(6) = 1.57 repeat result from (b)(6) = 1.36 difference of 15.44%.Sid (b)(6) initial result from (b)(6) = 1.60 repeat result from (b)(6) = 1.44 difference of 11.11%.Sid (b)(6) initial result from (b)(6) = 1.51 repeat result from (b)(6) = 1.25 difference of 20.80%.Sid (b)(6) initial result from (b)(6) = 1.63 repeat result from (b)(6) = 1.36 difference of 19.85%.Sid (b)(6) initial result from (b)(6) = 1.55 repeat result from (b)(6) = 1.32 difference of 17.42%.Sid (b)(6) initial result from (b)(6) = 1.53 repeat result from (b)(6) = 1.37 difference of 11.68%.Sid (b)(6) initial result from (b)(6) = 1.52 repeat result from (b)(6) = 1.32 difference of 15.15%.Sid (b)(6) initial result from (b)(6) = 1.81 repeat result from (b)(6) = 1.46 difference of 23.97%.Sid (b)(6) initial result from (b)(6) = 1.64 repeat result from (b)(6) = 1.34 difference of 22.39%.Sid (b)(6) initial result from (b)(6) = 1.53 repeat result from (b)(6) = 1.29 difference of 18.60%.Sid (b)(6) initial result from (b)(6) = 1.65 repeat result from (b)(6) = 1.41 difference of 17.02%.Sid (b)(6) initial result from (b)(6) = 1.61 repeat result from (b)(6) = 1.23 difference of 30.89%.Sid (b)(6) initial result from (b)(6) = 1.65 repeat result from (b)(6) = 1.46 difference of 13.01%.Sid (b)(6) initial result from (b)(6) = 1.51 repeat result from (b)(6) = 1.34 difference of 12.69%.There was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Complete information for section a1 patient identifier: sid (b)(6).
Event or Problem Description
The customer observed a falsely increased architect free t4 result for multiple patients on architect i2000sr, serial number (b)(6).The results were not reported out.The samples were repeated on other architect i2000srs, serial numbers (b)(6), with lower results.The following data was provided: sid (b)(6) initial result from (b)(6) = 1.64 repeat result from (b)(6) = 1.42 difference of 15.49%.Sid (b)(6) initial result from (b)(6) = 1.51 repeat result from (b)(6) = 1.34 difference of 12.69%.Sid (b)(6) initial result from (b)(6) = 1.62 repeat result from (b)(6) = 1.47 difference of 10.20%.Sid (b)(6) initial result from (b)(6) = 1.72 repeat result from (b)(6) = 1.47 difference of 17.01%.Sid (b)(6) initial result from (b)(6) = 1.65 repeat result from (b)(6) = 1.30 difference of 26.92%.Sid (b)(6) initial result from (b)(6) = 1.57 repeat result from (b)(6) = 1.36 difference of 15.44%.Sid (b)(6) initial result from (b)(6) = 1.60 repeat result from (b)(6) = 1.44 difference of 11.11%.Sid (b)(6) initial result from (b)(6) = 1.51 repeat result from (b)(6) = 1.25 difference of 20.80%.Sid (b)(6) initial result from (b)(6) = 1.63 repeat result from (b)(6) = 1.36 difference of 19.85%.Sid (b)(6) initial result from (b)(6) = 1.55 repeat result from (b)(6) = 1.32 difference of 17.42%.Sid (b)(6) initial result from (b)(6) = 1.53 repeat result from (b)(6) = 1.37 difference of 11.68%.Sid (b)(6) initial result from (b)(6) = 1.52 repeat result from (b)(6) = 1.32 difference of 15.15%.Sid (b)(6) initial result from (b)(6) = 1.81 repeat result from (b)(6) = 1.46 difference of 23.97%.Sid (b)(6) initial result from (b)(6) = 1.64 repeat result from (b)(6) = 1.34 difference of 22.39%.Sid (b)(6) initial result from (b)(6) = 1.53 repeat result from (b)(6) = 1.29 difference of 18.60%.Sid (b)(6) initial result from (b)(6) = 1.65 repeat result from (b)(6) = 1.41 difference of 17.02%.Sid (b)(6) initial result from (b)(6) = 1.61 repeat result from (b)(6) = 1.23 difference of 30.89%.Sid (b)(6) initial result from (b)(6) = 1.65 repeat result from (b)(6) = 1.46 difference of 13.01%.Sid (b)(6) initial result from (b)(6) = 1.51 repeat result from (b)(6) = 1.34 difference of 12.69% 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, and in-house testing of a retained reagent kit.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.The ticket search by lot indicates that the reagent lot shows elevated complaint activity.A review of tracking and trending did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances, potential non-conformances, or deviations with the complaint lot.Retained analysis of architect free t4 reagent lot 50481ud00.Testing met acceptance criteria and the product is performing as expected.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency with the architect free t4 reagent kit, lot number 50481ud00, 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: 18702908
• Report Number: 3005094123-2024-00060
• Device Sequence Number: 20660338
• 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): 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): 02/19/2024

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: 03/06/2024
• Device Catalogue Number: 07K65-34
• Device Lot Number: 50481UD00
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2023
• 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
• 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