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	03/13/2024
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.Section b5 descibe event or problem was updated with: additional data for two more patients provided (b)(6) 2024: 1st sample = initial result = 2.37 repeat 1.13 ng/dl.2nd sample = initial result = 2.03 repeat 1.21 ng/dl.
Event or Problem Description
The customer observed falsely elevated architect free t4 results for four patients on architect i2000sr, serial numbers (b)(6).The results were lower when the samples were repeated.The following data was provided: (b)(6): (b)(6) 2024.Sample 1: initial test: >5 ng/dl.Retest: 1.22 ng/dl.(b)(6) 2024.Initial test: >5 ng/dl.Retest: 1.28 ng/dl.Another device: (b)(6): sample 3: initial test: 2.79 ng/dl.Retest: 1.19 ng/dl.Sample 4: initial test: 2.05 ng/dl.Retest: 1.31 ng/dl.Additional data for two more patients provided (b)(6) 2024: 1st sample = initial result = 2.37 repeat 1.13 ng/dl.2nd sample = initial result = 2.03 repeat 1.21 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, search for similar complaints, ticket trending review, device history record review, and labeling review.Additionally, in-house testing was performed.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.A search for similar complaints did identify an increase in complaint activity, however, no related trends were identified regarding commonalities for lot number 56001ud00 and issue for the product.Additionally, in-house performance testing was completed which indicates the product is performing as expected.The device history record review did not identify any nonconformances, potential nonconformances or deviations associated with lot number 56001ud00 and the complaint issue.Labeling was reviewed and adequately addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect free t4 for lot 56001ud00 was identified.Section d4 catalog number and primary udi updated to (b)(4) with size code change from 24apr2024.
Event or Problem Description
The customer observed falsely elevated architect free t4 results for four patients on architect i2000sr, serial numbers (b)(6).The results were lower when the samples were repeated.The following data was provided: (b)(6): (b)(6) 2024 sample 1: initial test: >5 ng/dl retest: 1.22 ng/dl.(b)(6) 2024 sample 2: initial test: >5 ng/dl retest: 1.28 ng/dl.Another device: (b)(6): sample 3: initial test: 2.79 ng/dl retest: 1.19 ng/dl.Sample 4: initial test: 2.05 ng/dl retest: 1.31 ng/dl.Additional data for two more patients provided (b)(6) 2024: 1st sample = initial result = 2.37 repeat 1.13 ng/dl 2nd sample = initial result = 2.03 repeat 1.21 ng/dl no impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated architect free t4 results for four patients on architect i2000sr, serial numbers (b)(6).The results were lower when the samples were repeated.The following data was provided: (b)(6): (b)(6) 2024 sample 1: initial test: >5 ng/dl retest: 1.22 ng/dl (b)(6) 2024 sample 2: initial test: >5 ng/dl retest: 1.28 ng/dl another device: (b)(6): sample 3: initial test: 2.79 ng/dl retest: 1.19 ng/dl sample 4: initial test: 2.05 ng/dl retest: 1.31 ng/dl no impact to patient management was 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: 19011422
• Report Number: 3005094123-2024-00149
• Device Sequence Number: 15448885
• Product Code: CEC
• UDI-Device Identifier: 00380740119805
• UDI-Public: (01)00380740119805(17)240926(10)56001UD00
• 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,Followup
• Report Date (Section B): 05/01/2024

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: 07K65-34
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: 04/02/2024; 04/24/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 04/17/2024; 05/01/2024
• 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
• 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).; ARC I2K PROC MOD, 03M74-01, (B)(6).
• Patient Sex: Unknown