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

Model Number FT4 G3

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

Manufacturer Narrative

For 1 of the events, the patient sample was submitted for investigation.The investigation did not identify a product problem.The cause of the event could not be determined.Assays from different manufacturers can generate different results.For 1 of the events, the investigation could not identify a product problem.The cause of the event could not be determined.For 1 of the events, the investigation is ongoing.The follow up/corrective actions for 1 of the events was the sample was requested for investigation.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 results were generated by a cobas 6000 e 601 module.The events involved a total of 3 patients with elecsys ft4 iii assay.The provided patients' ages ranged from 39 to 85 years.There were 2 females and 1 male.

Manufacturer Narrative

The investigation of the remaing, open event determined the patient sample contained an interferent to a component of the elecsys ft4 ii assay.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8615534
• MDR Text Key: 145389149
• Report Number: 1823260-2019-90165
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 07613336153956
• UDI-Public: 7613336153956
• Combination Product (y/n): N
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Device Model Number: FT4 G3
• Device Lot Number: 378826
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2019
• Patient Sequence Number: 1