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 found for one of the events the questionable results were between 2 different reagent lots and 2 e602 modules.The investigation did not identify a product problem.The cause of the event could not be determined.For two of the events, the investigation did not identify a product problem.The cause of the event could not be determined.The investigation found for one of the events from the data provided, a general reagent issue can be excluded.Assays from different manufacturers can generate different results.This relates to the overall setup of the assays, the antibodies used and differences in reference materials and standardization methodology.The investigation did not identify a product problem.The cause of the event could not be determined.The follow up/corrective actions for one of the events was the sample was requested for investigation but there was insufficient sample material remaining.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 4 malfunction events.Questionable non-reproducible results were generated by elecsys ft4 iii.The events involved a total of 16 patients with the following: 14 cobas 8000 e 602 module; 1 cobas e 411 immunoassay analyzer; 1 cobas 6000 e 601 module.The provided patients' ages ranged from 25 to 88 years.There were 2 females.

• 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: 8830183
• MDR Text Key: 152672795
• Report Number: 1823260-2019-90208
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Number of Events Reported: 4
• 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

• Date FDA Received: 07/26/2019
• 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: 378826, 391521, ASKU
• Type of Device Usage: N
• Patient Sequence Number: 1