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

Model Number FT4 G3

Device Problem Low Test Results (2458)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The investigation has not been completed.The follow up/corrective actions for the event was that the sample was requested for investigation.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 low results were generated by the cobas 8000 e 602 module.The events involved a total of 1 patient with the following: one erroneous result for elecsys ft4 iii.The patient's age was requested, but not provided.The patient's weight was requested, but not provided.The patient's gender was requested, but not provided.The patient's race was requested, but not provided.The patient's ethnicity was requested, but not provided.

Manufacturer Narrative

For the remaining event, sample from the patient could not be provided for investigation.Therefore further investigation could not be completed.The investigation did not identify a product problem.The cause of the event could not be determined.A general reagent issue could be excluded.

• 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: 8284606
• MDR Text Key: 134361591
• Report Number: 1823260-2019-90069
• 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

• Date FDA Received: 01/29/2019
• 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
• Patient Sequence Number: 1