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

For all three events, the investigation could not identify a product problem.The cause of the events could not be determined.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.Erroneous low elecsys ft4 ii assay results were generated.The events involved a total of 3 patients.The provided patients' ages ranged from "30s" to (b)(6).The other patient's age was requested but were not provided.The patients' weights were requested but were not provided.The provided patient genders were 2 males.The other patient's gender was requested but was not provided.The patients' races were requested but were not provided.The patients' ethnicities were requested but were not provided.

• 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: 8284319
• MDR Text Key: 134463784
• Report Number: 1823260-2019-90036
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 04015630930920
• UDI-Public: 4015630930920
• 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

• Date FDA Received: 01/29/2019
• 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: 33670100, ASKU
• Type of Device Usage: N
• Patient Sequence Number: 1