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

Model Number FT4 G3

Device Problem Non Reproducible Results (4029)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation has yet to be determined.The follow-up action has yet to be determined.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.Questionable non-reproducible results for the elecsys ft4 iii assay.The events involved 1 patient that was tested on a cobas 6000 e 601 module and a cobas 8000 e 602 module.The patient was (b)(6) years old.The patient's weight was requested but was not provided.The patient was a female.The patient's race was requested but was not provided.The patient's ethnicity was requested but was not provided.

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.The follow up actions for this event were: there were no follow up actions.No sample was returned for investigation.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 9238183
• MDR Text Key: 219582051
• Report Number: 1823260-2019-90253
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 07613336153956
• UDI-Public: 7613336153956
• 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 G3
• Device Lot Number: ASKU
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2020
• Patient Sequence Number: 1