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

Model Number FT4 G3

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 of the events determined that a general reagent issue most likely can be excluded.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and the standardization methodology used.All values are within the respective assay reference ranges.With the ft4ii and ft4iii assay versions, no significantly different values are generated.The investigation for 1 of the events is ongoing.There were no follow up/corrective actions.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 by a cobas 8000 e 602 module and a cobas 6000 e 601 module.The events involved a total of 2 patients with the elecsys ft4 iii assay.The age for 1 patient was (b)(6) years.The patients 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 iii assay.This limitation is covered in product labeling.

• 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: 8556081
• MDR Text Key: 143694764
• Report Number: 1823260-2019-90152
• 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: 04/26/2019
• Device Operator: No Information
• Device Model Number: FT4 G3
• Device Lot Number: ASKU, 341685
• Patient Sequence Number: 1