MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 IV; FREE THYROXINE

Model Number	FT4 IV
Medical Device Problem Codes	Signal Artifact/Noise (1036); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys ft4 iv assay results with two samples from one patient tested on a cobas e 801 analytical unit when compared to a competitor test.Sample 1 (b)(6) 2025): the result using the architect assay was 1.37 ng/dl.The result using the e801 was 2.32 ng/dl.On (b)(6) 2025, anti-t4 antibodies were determined and were negative.The sample was incubated with microparticles for the study of streptavidin and biotin interference; the result was ft4: 2.42 ng/dl.The sample was also treated with hbr scantibodies tubes to eliminate interference from heterophile antibodies; the result was ft4: 2.40 ng/dl.Sample 2 (b)(6) 2025): the result using the e801 was 2.41 ng/dl.
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The sample material was requested for investigation.
Additional Manufacturer Narrative
The sample material was sent for investigation.The customer result was confirmed.Upon further investigation of the sample with different research toolboxes, no assay interference for the ft4 assay was detected.The value differences obtained with the ft4 assays relate to the differences in the setup of the assays, the antibodies used, and the differences in the standardization materials and procedures used.For diagnostic purposes, the results should always be assessed in conjunction with the patient´s medical history, clinical examination and other findings.The investigation did not identify a product problem.

• Brand Name: ELECSYS FT4 IV
• Common Device Name: FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23655732
• Report Number: 1823260-2025-04859
• Device Sequence Number: 15983426
• Product Code: CEC
• UDI-Device Identifier: 07613336172780
• UDI-Public: 07613336172780
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K220456
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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 Model Number: FT4 IV
• Device Catalogue Number: 09043284190
• Device Lot Number: 852514
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 58 YR
• Patient Sex: Male