MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT3 III; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Model Number FT3 G3

Device Problem Non Reproducible Results (4029)

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, a general reagent issue can be excluded.Assays from different manufacturers can generate different results.The investigation did not identify a product problem.The cause of the event could not be determined the follow up action for 1 event was that the sample was requested for investigation but there was insufficient sample material remaining.There was no follow up action for 1 event.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 2 malfunction events.Non-reproducible results were generated by the elecsys ft3 iii assay on 2 cobas 6000 e 601 modules.The events involved a total of 2 patients.1 patient was (b)(6) years.1 patient was male.

• Brand Name: ELECSYS FT3 III
• Type of Device: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• 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: 8830168
• MDR Text Key: 152669787
• Report Number: 1823260-2019-90184
• Device Sequence Number: 1
• Product Code: CDP
• Combination Product (y/n): N
• Number of Events Reported: 2
• 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: FT3 G3
• Device Lot Number: ASKU
• Type of Device Usage: N
• Patient Sequence Number: 1