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

Model Number	09043284190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient sample was requested for investigation.
Event or Problem Description
The initial reporter received questionable elecsys ft3 iii ver.2, elecsys ft4 iii assay and elecsys ft4 iv assay results from one patient sample tested on the customer's cobas 8000 core unit and the investigation site's cobas e 801 module.This mdr is for the ft4 iv assay.Please refer to medwatch with: a1.Patient identifier (b)(6) for the ft3 iii assay.A1.Patient identifier (b)(6) for the ft4 iii assay.The reporter suspects interference with t3 monoclonal antibodies.The patient sample was rerun on the customer's wako accuraseed and abbott alinity.The patient sample was also sent to the investigation site for reruns.Please refer to the attachment (b)(6) in the medwatch for the table containing the highlighted questionable results.
Additional Manufacturer Narrative
The patient sample was received for investigation.The investigation tested the patient sample for ft3iii, ft3 iii v2, ft4 iii, and ft4 iv using commercially available assay versions; similar results were obtained.No interference was detected.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials, and the standardization methodology used.Product labeling states: "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.
Additional Manufacturer Narrative
**udi related data quality updates only** d3 is the initial distributor in the us.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18327471
• Report Number: 1823260-2023-04002
• Device Sequence Number: 7081542
• Product Code: CEC
• UDI-Device Identifier: 07613336172780
• UDI-Public: 07613336172780
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 08/29/2024

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: 10/31/2024
• Device Model Number: 09043284190
• Device Catalogue Number: 09043284190
• Device Lot Number: 749372
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2023
• Supplement Date Received by Manufacturer: 03/19/2024; 08/29/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 04/10/2024; 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 76 YR
• Patient Sex: Male