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 investigation did 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 provided for investigation.For reagent: 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.Questionable low results were generated by a cobas 8000 e 602 module and a cobas 6000 e 601 module.The events involved a total of 2 patients for elecsys ft4 iii assay.The patients' ages were requested but were not provided.The patients' weights were requested but were not provided.The patients' genders were requested but were not provided.The patients' races were requested but were not provided.The patients' ethnicities were requested but were not provided.

Manufacturer Narrative

For the one pending event, the investigation determined the ft4 iii results were correct.A product problem was not found.The follow up actions were that 4 samples from the patient were submitted for investigation.

• 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: 9238187
• MDR Text Key: 219403656
• Report Number: 1823260-2019-90254
• Device Sequence Number: 1
• Product Code: CEC
• 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 G3
• Device Lot Number: ASKU, 391521
• Patient Sequence Number: 1