MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 III; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number 07976887190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2023

Event Type  malfunction  

Manufacturer Narrative

The patient sample was requested for investigation.

Event 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 iii assay.Please refer to medwatch with: a1.Patient identifier (b)(6) for the ft3 iii assay.A1.Patient identifier (b)(6) for the ft4 iv 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.

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.

• Brand Name: ELECSYS FT4 III
• Type of Device: RADIOIMMUNOASSAY, 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: 18327475
• MDR Text Key: 330505325
• Report Number: 1823260-2023-04003
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male