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

Model Number FT3 G3

Device Problem Non Reproducible Results (4029)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

For 1 event, the investigation did not identify a product problem.The cause of the event could not be determined.For 1 event, the investigation is ongoing.There were no follow up actions for 2 events.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 2 malfunction events.Questionable non-reproducible results were generated by the elecsys ft4 iii assay on 1 cobas 8000 e 602 module and 2 cobas 6000 e 601 modules.The events involved a total of 2 patients.

Manufacturer Narrative

For the one pending event, a second sample from the same patient also had discrepant results for the elecsys ft4 iii assay on a cobas 8000 e 602 module and a cobas 6000 e 601 module.For this event, a sample from the patient was provided for investigation and the investigation determined the sample contains a factor that interferes with the streptavidin component of the ft4 assay.Per product labeling: "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." there were no follow up actions for this event.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis, in
• MDR Report Key: 10331989
• MDR Text Key: 202410602
• Report Number: 1823260-2020-90111
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FT3 G3
• Device Lot Number: ASKU, 443835
• Patient Sequence Number: 1