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

Model Number FT4 G3

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

For 1 event, the investigation could not identify a product problem.The cause of the event could not be determined.For 3 events, the investigation could not identify a product problem.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 differences in the standardization methodology used.For 1 event, the investigation is ongoing.There were no follow up actions for 5 events.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 5 malfunction events.Questionable high results were generated by the elecsys ft4 iii assay on 6 cobas 8000 e 602 modules, 1 cobas 6000 e 601 module and 1 cobas e 801 module.The events involved a total of 6 patients.The patients' ages ranged from 26 years to 89 years.The other patients' ages were requested, but were not provided.The patients' weights were requested, but were not provided.There were 3 females and 1 male.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 the one pending event, the patient's sample was provided for investigation.The investigation reproduced and confirmed the customer's ft4 result.The investigation did not identify a product problem.The cause of the event could not be determined.The difference in results from assay by different manufacturers could be due to differences in the setups of the assays, the antibodies used, and differences in the standardization materials and procedures used.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis, in
• MDR Report Key: 10331864
• MDR Text Key: 202537244
• Report Number: 1823260-2020-90113
• 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

• 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, 443835, 426281
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/22/2020
• Patient Sequence Number: 1