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

Model Number FT4 G2

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

Manufacturer Narrative

The investigations found: 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 did not identify a product problem.The cause of the event could not be determined.Assays from different vendors can generate different values due to the overall setups of the assays, the antibodies used, and differences in reference materials/methods and the standardization methodology used.The follow up/corrective actions were: for 1 event: the sample was requested for investigation but was not provided.For 1 event: there was no follow up / corrective action.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.Erroneous low results were generated for elecsys ft4 ii assay.The events involved a total of 2 patients that were tested on the following instruments: 1 patient tested on a cobas e 801 module.1 patient tested on an investigation site's cobas 8000 e 601 module compared to the siemens centaur method.For the 2 patients, the patients' ages ranged from 26 to 83 years.There were 1 female and 1 male.

• Brand Name: ELECSYS FT4 II ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofferstrasse 116; na; mannheim (baden-wurttemberg), na 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 8549734
• MDR Text Key: 143414528
• Report Number: 1823260-2019-90134
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 04015630939725
• UDI-Public: 04015630939725
• Combination Product (y/n): N
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Device Model Number: FT4 G2
• Device Lot Number: 36319500, 336701
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2019
• Type of Device Usage: N
• Patient Sequence Number: 1