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

Model Number FT4 G3

Device Problem High Test Results (2457)

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

Event Date 12/15/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation could not identify a product problem.Assays from different vendors can generate different values.This is related to the different types of antibodies used, differences in setups of the assays, and differences in the standardization methodologies.The roche and abbott assays also use different calculations for the determination of normal reference ranges.Normal reference ranges vary in function of the patient cohort used.Each laboratory should investigate the transferability of the expected values to its own patient population.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys ft4 iii assay on a cobas 8000 e 801 module (serial number 19h8-07).No incorrect results were reported outside of the laboratory.The sample initially resulted in a ft4 value of 25.8 pmol/l (reference range = 12 - 22 pmol/l) when tested on the e 801 analyzer.The sample was repeated using the abbott alinity ci method, resulting in a value of 17.606 pmol/l (reference range = 9 - 19 pmol/l) on (b)(6) 2022.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16117582
• MDR Text Key: 308574208
• Report Number: 1823260-2023-00081
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: 630888
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• 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