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

Model Number FT4 G2

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

Lot numbers continued: asku, asku.For all 5 events a general reagent issue can be excluded.Assays from different manufacturers can generate different results.This relates to the overall set up 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.The follow up actions for 2 events was that the samples were requested for investigation but sufficient sample material could not be provided.There were no follow up actions for 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 5 malfunction events.High results were generated by the elecsys ft4 ii assay on 2 cobas 6000 e 602 modules, 2 cobas 6000 e 601 modules and 1 cobas e801 module.The events involved a total of 6 patients.The patients' ages ranged from 29 to 79 years.There were 2 females 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; sandhoferstrasse 116; mannheim (baden-wurttemberg), 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 8830177
• MDR Text Key: 152671694
• Report Number: 1823260-2019-90195
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 G2
• Device Lot Number: 361887, 361887, 361887
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2019
• Type of Device Usage: N
• Patient Sequence Number: 1