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	02/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 - patient identifier: sids = (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 results generated on the architect i2000sr processing modules for a patient when using a sample collected in plasma separating tube (pst).A new sample from the patient was collected in edta tube and the results were lower.The following data was provided: customer¿s normal reference range for adult: 9 to 19 pmol/l.(b)(6) 2024 sid (b)(6) (sample collected in pst): architect free t4 result (b)(6) = 21.42 pmol/l architect free t4 result (b)(6) = 43.17 pmol/l architect free t4 result (b)(6) = 25.79 pmol/l architect free t4 result (b)(6) = 43.99 pmol/l architect free t4 result (b)(6) = 47.83 pmol/l architect free t4 result (b)(6) = 61.64 pmol/l (post recalibration) (b)(6) 2024 sid (b)(6) (sample collected in edta): architect free t4 result (b)(6) = 13.38 pmol/l.Architect free t4 result (b)(6) = 14.09 pmol/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
Section d4 - primary udi number: this section was corrected from (b)(4).The complaint investigation for falsely elevated architect free t4 results included a review of data and information provided by the customer, ticket trending review, device history record review, and labeling review.In addition, in-house testing of retained reagent kit was also completed.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.A review of the complaint trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with lot number 56001ud00 and the complaint issue.An in-house testing of the retained reagent kit of lot 56001ud00 was completed.All specifications were met indicating that lot 56001ud00 is performing as expected.A review of labeling was performed and found to sufficiently address the customer's issue.Based on this investigation, no systemic issue or deficiency was identified with the architect free t4 reagent, lot number 56001ud00.
Event or Problem Description
The customer observed falsely elevated architect free t4 results generated on the architect i2000sr processing modules for a patient when using a sample collected in plasma separating tube (pst).A new sample from the patient was collected in edta tube and the results were lower.The following data was provided: customer¿s normal reference range for adult: 9 to 19 pmol/l (b)(6) (sample collected in pst): architect free t4 result ((b)(6)) = 21.42 pmol/l architect free t4 result ((b)(6)) = 43.17 pmol/l architect free t4 result ((b)(6)) = 25.79 pmol/l architect free t4 result ((b)(6)) = 43.99 pmol/l architect free t4 result ((b)(6)) = 47.83 pmol/l architect free t4 result ((b)(6)) = 61.64 pmol/l (post recalibration).(b)(6) (sample collected in edta): architect free t4 result ((b)(6)) = 13.38 pmol/l architect free t4 result ((b)(6)) = 14.09 pmol/l there was no impact to patient management 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: 18856645
• Report Number: 3005094123-2024-00097
• Device Sequence Number: 12821650
• Product Code: CEC
• UDI-Device Identifier: 00380740119805
• UDI-Public: (01)00380740119805(17)240926(10)56001UD00
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/17/2024

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): Initial
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/18/2024
• 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 I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).
• Patient Sex: Unknown