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	02/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Completed information for section a1 patient identification: sids (b)(6).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 multiple patient samples.The following data was provided (customer¿s reference range 0.70-1.48 ng/dl): (b)(6) 2024 sample id (b)(6) initial result on analyzer (b)(6) = 3.12 ng/dl, repeat on same analyzer = 1.46 ng/dl.Sample id (b)(6) initial result on analyzer (b)(6) = 1.7 ng/dl, repeat result on analyzer (b)(6) = 1.33 ng/dl.Sample id (b)(6) initial result on analyzer (b)(6) = 1.43 ng/dl, repeat on analyzer (b)(6) = 0.95 ng/dl.Sample id (b)(6) initial result on analyzer (b)(6) = 1.83 ng/dl, repeat on analyzer (b)(6) = 1.25 ng/dl.Sample id (b)(6) initial result on analyzer (b)(6) = 1.54 ng/dl, repeat result on analyzer (b)(6) = 1.17 ng/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
Section d4 - primary udi number: this section was corrected from (b)(4).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.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 56001ud01 and issue for the product.Additionally, in-house performance testing was completed which indicates the product is performing as expected.Device history record review did not identify any non-conformances, potential non-conformances, or deviations associated with lot number 56001ud01 and the complaint issue.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the architect free t4, lot 56001ud01, was identified.
Event or Problem Description
The customer observed falsely elevated architect free t4 results for multiple patient samples.The following data was provided (customer¿s reference range 0.70-1.48 ng/dl): (b)(6) 2024.Sample id (b)(6) initial result on analyzer (b)(6) = 3.12 ng/dl, repeat on same analyzer = 1.46 ng/dl.Sample id (b)(6) initial result on analyzer (b)(6) = 1.7 ng/dl, repeat result on analyzer (b)(6) = 1.33 ng/dl.Sample id (b)(6) initial result on analyzer (b)(6) = 1.43 ng/dl, repeat on analyzer (b)(6) = 0.95 ng/dl.Sample id (b)(6) initial result on analyzer (b)(6) = 1.83 ng/dl, repeat on analyzer (b)(6) = 1.25 ng/dl.Sample id (b)(6) initial result on analyzer (b)(6) = 1.54 ng/dl, repeat result on analyzer (b)(6) = 1.17 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: 18831879
• Report Number: 3005094123-2024-00091
• Device Sequence Number: 14192495
• 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): 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): 05/09/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 05/09/2024
• 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); ARC I2K PROC MOD,03M74-01, (B)(6)
• Patient Sex: Unknown