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

Model Number FT4

Device Problem High Test Results (2457)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

For this event, the investigation is ongoing.There were no follow up actions for this event.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

Questionable high results were generated by the elecsys ft4 assay assay on a cobas e411 rack analyzer.The event involved a total of 1 patient.The patient's age was requested but was not provided.The patient's weight was requested but was not provided.The patient was 1 female.The patient's race was requested but was not provided.The patient's ethnicity was requested but was not provided.

Manufacturer Narrative

For the one pending event, an interfering factor was detected in the patient 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.".

• Brand Name: ELECSYS FT4 ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 10753994
• MDR Text Key: 231158399
• Report Number: 1823260-2020-90151
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FT4
• Device Lot Number: ASKU
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2021
• Patient Sequence Number: 1