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 found for one of the events from the data provided, a general reagent issue can be excluded.Assays from different manufacturers can generate different results.This relates to the overall setup of the assays, the antibodies used and differences in reference materials and standardization methodology.The investigation did not identify a product problem.The cause of the event could not be determined.For one of the events, the investigation is ongoing.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 non-reproducible results were generated by elecsys ft4 ii assay.The events involved a total of 2 patients with the following: 2 cobas 8000 e 602 module.The provided patient's age was 25 years.There were 2 females.

Manufacturer Narrative

The investigation determined the sample contained an interferent to a component of the ft4 ii assay.This limitation is covered in product labeling.There were no follow-up actions for this event.

• 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: 8830185
• MDR Text Key: 152667980
• Report Number: 1823260-2019-90209
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 04015630930920
• UDI-Public: 4015630930920
• Combination Product (y/n): N
• Number of Events Reported: 2
• 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

• 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: FT4 G2
• Device Lot Number: 361887
• Patient Sequence Number: 1