MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FT3 - FREE TRIIODOTHYRONINE; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Model Number FT3 V2

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.There were no follow up/corrective actions.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event.An erroneous high result was generated by the cobas 6000 e 601 module.The events involved a total of 1 patient with the following: one erroneous result for the elecsys ft3 assay.The patient's age was (b)(6).There was one male.

• Brand Name: FT3 - FREE TRIIODOTHYRONINE
• 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: 8544218
• MDR Text Key: 143403772
• Report Number: 1823260-2019-90105
• Device Sequence Number: 1
• Product Code: CDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 V2
• Device Lot Number: ASKU
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2019
• Type of Device Usage: N
• Patient Sequence Number: 1