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

Model Number FT3 G3

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 the 2 events that the cause of the event could not be determined.The investigation did not identify a product problem.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: there was no follow up/corrective action.For 1 event: the sample was submitted for preliminary investigation and tested on an e411 analyzer and the centaur method.For reagents: 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 ft3 iii.The events involved a total of 2 patients with the following: 1 patient had erroneous result from a cobas e 411 immunoassay analyzer.1 patient had erroneous result from a cobas 8000 e 601 module compared to the siemens centaur method.One patient was (b)(6).One patient was female.

• Brand Name: ELECSYS FT3 III
• Type of Device: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• 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: 8549752
• MDR Text Key: 143414931
• Report Number: 1823260-2019-90115
• Device Sequence Number: 1
• Product Code: CDP
• 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

• 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: 314666, 341685
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2019
• Type of Device Usage: N
• Patient Sequence Number: 1