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 3 of the events: the investigation did not identify a product problem.Assays from different manufacturers can generate different results.This relates to differences in the antibodies used, standardization methods and measuring principles.For 3 of the events: the investigation is ongoing.For 1 of the events: the sample was returned for investigation.The customer's roche results were reproduced.Interference testing was performed and no interfering factors were identified.The investigation did not identify a product problem.The cause of the event could not be determined.The reported event involved an automated analytical device which is serviced in the field and not routinely returned for investigation.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 7 malfunction events.Questionable high elecsys ft4 ii results were generated by cobas 8000 e 602 modules, cobas e 411 immunoassay analyzers, and cobas 6000 e 601 modules.The events involved a total of 7 patients.The known patients' ages ranged from 39 to 81 years.There were known to be 2 females and 2 males.

Manufacturer Narrative

For one event, 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 the standardization methodology used.There were no follow up actions for this event.For one event, the investigation could not identify a product problem.The cause of the event could not be determined.Follow up actions for this event include: the patient sample was provided for investigation and the results measured by the customer could be reproduced.For one event, investigation of the sample found an interfering factor against sru label.This interference is covered by a disclaimer in the section limitation - interference in the method sheets of all applicable products: in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.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: 9638533
• MDR Text Key: 209821958
• Report Number: 1823260-2020-90031
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Number of Events Reported: 7
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2020
• Patient Sequence Number: 1