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 12/08/2022

Event Type  malfunction  

Event Description

The initial reporter received questionable elecsys ft4 iii assay results from one patient sample tested on the customer's cobas e411 rack with serial number (b)(4) and an investigation site's cobas e 411 analyzer with serial number (b)(4).The initial result was not reported outside of the laboratory.The reporter suspected the presence of macro tsh because the tsh was higher than the ft4, and some nonspecific interference in the roche assays.The reporter sent the patient sample to an investigation site.A discrepancy was noted between the ft4 iii results of the customer and the investigation site.The patient sample was then sent to an outsourced laboratory.The reagent lot number used at the investigation site's e 411 is 623234.The expiration date is 30-apr-2023.

Manufacturer Narrative

From the information provided and the analysis thereof, a general reagent issue can most likely be excluded.The differences generated between the different methods most likely relate to methodological differences.To the differences in the values generated with the different analyzers, it needs to be taken into account that assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.In case a sample is analyzed with different analyzers, the generated values are to be interpreted in relation to the normal reference ranges of the assays of the different analyzers.

• 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: 16215130
• MDR Text Key: 308382545
• Report Number: 1823260-2023-00196
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• 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
• Report Date: 01/20/2023

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
• Device Operator: Health Professional
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: ASKU, 623234
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/20/2023
• 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
• Treatment: LEVOTHYROXINE; LIOTHYRONINE