MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT FREE T4 (6 POINT CALIBRATOR ASSAY); RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number	07K65-77
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
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.
Event or Problem Description
The customer observed falsely elevated architect free t4 results for one patient.The initial result was 32.17 pmol/l, recheck result was 17.66 pmol/l (reference range: 9.01-19.05 pmol/l).No impact to patient management was reported.
Additional Manufacturer Narrative
Additional patient results added to the ticket on (b)(6) 2024.Initial ft4 test result was 21.11 pmol/l, recheck result was 16.38 pmol/l.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.H3 other text : device evaluation is in progress.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Corrected data found in section d4 catalog # and lot #.
Additional Manufacturer Narrative
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, however, in-house performance testing was completed which indicates the product is performing as expected.Device history review did not identify any issues associated with the customer¿s observation.A review of ticket trending did not identify any related trend regarding commonalities for complaint lot number and issue.In-house performance testing was completed which indicates the product is performing as expected.Labeling review concludes that the issue is adequately addressed.Based on the investigation, no systemic issue or deficiency of the architect free t4 assay was identified.

• Brand Name: ARCHITECT FREE T4 (6 POINT CALIBRATOR ASSAY)
• 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: 18691431
• Report Number: 3005094123-2024-00058
• Device Sequence Number: 15543246
• Product Code: CEC
• UDI-Device Identifier: 00380740119805
• UDI-Public: 00380740119805
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup,Followup
• Report Date (Section B): 05/02/2024

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: 07K65-77
• Device Lot Number: 50481UD02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 02/19/2024; 03/20/2024; 04/14/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 03/11/2024; 04/09/2024; 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2023
• 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, ISR51280.; ARC I2000SR INST, 03M74-02, ISR51280.; ARC I2000SR INST, 03M74-02, ISR51280.; ARC I2000SR INST, 03M74-02, ISR51280.
• Patient Sex: Unknown