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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

For 1 event, a general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.For 1 event, the numerical difference in observed values relates to the fact that assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, and differences in reference materials and the standardization methodology used.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.There were no follow up actions for the 3 events.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 3 malfunction events.Low results were generated by the elecsys ft4 iii assay on 1 cobas 6000 e 602 module and 2 cobas 6000 e 601 modules.The events involved a total of 3 patients.The patients' ages ranged from 17 to 78 years.There were 2 males and 1 female.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; mannheim (baden-wurttemberg), 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 8830179
• MDR Text Key: 152680706
• Report Number: 1823260-2019-90196
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 07613336153956
• UDI-Public: 7613336153956
• Combination Product (y/n): N
• Number of Events Reported: 3
• 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: FT4 G3
• Device Lot Number: ASKU
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2019
• Type of Device Usage: N
• Patient Sequence Number: 1