MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT3 III; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

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

The investigations was ongoing.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event.Erroneous non-reproducible elecsys ft3 iii results were generated for 1 patient by the cobas 6000 e 601 module.The patient's age was requested, but was not provided.The patient's weight was requested, but was not provided.The patient's gender was requested, but was not provided.The patient's race was requested, but was not provided.The patient's ethnicity was requested, but was not provided.

Manufacturer Narrative

For the event, a second sample from the same patient also had discrepant results for the elecsys ft3 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 ft3 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 FT3 III
• Type of Device: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis, in
• MDR Report Key: 10331985
• MDR Text Key: 202529492
• Report Number: 1823260-2020-90103
• Device Sequence Number: 1
• Product Code: CDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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: FT3 G3
• Device Lot Number: ASKU
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/22/2020
• Patient Sequence Number: 1