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

Model Number FT4 G3

Device Problem High Test Results (2457)

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

Event Date 11/11/2021

Event Type  malfunction  

Manufacturer Narrative

The sample was requested for investigation.

Event Description

The initial reporter received questionable elecsys ft3 iii and elecsys ft4 iii results for one patient sample with the cobas e 801 module serial number unknown.The customer reported the ft4 results to a physician who asked for re-measurement of the sample.The sample was sent for an investigation and was tested on a cobas e801 module, cobas e602 module, cobas e 411 immunoassay analyzer, and a siemens centaur analyzer.The investigation site e801 module serial number was (b)(4).The e602 serial number was (b)(4).The e411 serial number was (b)(4).The ft4 reagent used at the investigation site on the e801 was lot number 541093 with an expiration date of 31-may-2022.The ft4 reagent used at the investigation site on the e602 and e411 was lot number 547168 with an expiration date of 31-may-2022.Refer to the attachment on the medwatch for all patient data.This medwatch is for ft4.Refer to the medwatch with patient identifier (b)(6) for the ft3 assay.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

A new sample collected from the patient was submitted for investigation.An interfering factor against sulforu-label of the assay could be identified in the sample.Product labeling for the assay states: in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin, or ruthenium can occur.These effects are minimized by suitable test design.No product problem could be found.

• Brand Name: ELECSYS FT4 III ASSAY
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13009641
• MDR Text Key: 287268734
• Report Number: 1823260-2021-03722
• 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,Followup,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• 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