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 investigations found: for 1 event: the investigation is currently ongoing.For 1 event: the investigation did not identify a product problem.The cause of the event could not be determined.Assays from different vendors can generate different values due to the overall setups of the assays, the antibodies used, and differences in reference materials/methods and the standardization methodology used.The follow up/corrective actions were: for 1 event: the follow up / corrective action is yet to be determined.For 1 event: there was no follow up / corrective action.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.Erroneous non-reproducible results were generated for elecsys ft4 ii assay.The events involved a total of 2 patients that were tested on the following instruments: 1 patient tested on a cobas 8000 e 602 module.1 patient tested on a cobas 8000 e 602 module and a cobas 6000 e 601 module used for investigation.1 patient was (b)(6).There were 2 females.

Manufacturer Narrative

For the one pending event, the investigation determined that the patient sample contained an interferent to a component of the elecsys ft4 ii assay.This limitation is covered in product labeling.

• 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: 8549731
• MDR Text Key: 143414742
• Report Number: 1823260-2019-90136
• Device Sequence Number: 1
• Product Code: CEC
• 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: 04/25/2019
• 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: 2 = ASKU
• Patient Sequence Number: 1