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 three events, the investigation did not identify a product problem.The cause of the event could not be determined.Assays from different manufacturers can generate different results.This relates to differences in the antibodies used, standardization methods and measuring principles.For two events, the investigation could not identify a product problem.The cause of the event could not be determined.There were no follow up actions for these events.For one event, the investigation did not identify a product problem.The cause of the event could not be determined.The follow up actions for this event were: the sample underwent preliminary investigation, however, there was no sample material remaining for further investigation.For one event, 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 follow up actions for this event were : the sample was requested for investigation.For six events, the investigations are still ongoing.The devices were not returned for investigation.This device is not labeled for single use and is not reprocessed or reused.Lot numbers cont'd: 39152103, 426281.

Event Description

This report summarizes 13 malfunction events.Questionable high elecsys ft4 iii results were generated by 10 cobas 8000 e 602 module analyzers, 4 cobas e 411 immunoassay analyzers, and 5 cobas 6000 e 601 module analyzers.The events involved 20 patient samples.Six patients' ages were between 3 and 83 years.The remaining patients' ages were requested, but not provided.The patients' weights were requested, but were not provided.There were three males and three females.The remaining patients' genders were requested, but not provided.The patients' races were requested, but were not provided.The patients' ethnicities were requested, but were not provided.

Manufacturer Narrative

For two events, the investigation could not identify a product problem.The cause of the events could not be determined.There were no follow up actions for these events.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 of the pending events, investigation of the patient sample found an interfering factor to streptavidin.This interference is documented in product labeling for the assay: in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.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 field service engineer performed multiple maintenance actions on the analyzer and replaced multiple parts.Performance testing was run and showed no issues.

• 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: 9638535
• MDR Text Key: 219782403
• Report Number: 1823260-2020-90033
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Number of Events Reported: 13
• 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: 01/28/2020
• 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, 410248,
• Patient Sequence Number: 1