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

Model Number FT4 G2

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

For seven of the events, the investigations could not identify a product problem.The cause of the events could not be determined.There were no follow up actions for these events.The investigations for two events are currently ongoing.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 9 malfunction events.Questionable high results were generated by six cobas 8000 e 602 module analyzers, two cobas e 601 analyzers, a roche diagnostics elecsys e170 modular analytics immunoassay analyzer, and an unknown roche immunochemistry analyzer.The events involved 15 patients with the following: 15 questionable results for elecsys ft4 ii.Three patient's ages ranged between newborn and in "60s" years.The other patients' ages were requested, but were not provided.The patients' weights were requested, but were not provided.There were three females.The other 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 one of the pending events, the investigation could not identify a product problem.The cause of the event could not be determined.There were no follow up actions for this event.For the other pending event, the investigation confirmed the presence of a streptavidin interfering factor.Product labeling states: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." the follow up actions were that 4 samples from the patient were submitted 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: 9238179
• MDR Text Key: 219400948
• Report Number: 1823260-2019-90252
• 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 G2
• Device Lot Number: 361887, ASKU, ASKU
• Patient Sequence Number: 1