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

Model Number FT4 G2

Device Problem Non Reproducible Results (4029)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.The follow up/corrective actions is to 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 1 malfunction events.Questionable non-reproducible results were generated by a cobas 6000 e 601 module and a cobas 8000 e 602 module.The event involved a total of 1 patient with elecsys ft4 ii assay.The provided patient's age was (b)(6) years.The patient's weight was requested but was not provided.The patient was a female.The patient's race was requested but was not provided.The patient's ethnicity was requested but was not provided.

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.The follow up actions for this event were: there were no follow up actions.No sample was returned for investigation.

• Brand Name: ELECSYS FT4 II ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 9238188
• MDR Text Key: 219403791
• Report Number: 1823260-2019-90251
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00015630934232
• UDI-Public: 015630934232
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• 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: ASKU
• Patient Sequence Number: 1