MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT3 III; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Model Number FT3 G3

Device Problem Low Test Results (2458)

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

Event Type  malfunction  

Manufacturer Narrative

For three events, the investigation could not identify a product problem.The cause of the event could not be determined.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 these events.For one event, the investigation is currently ongoing.The device was not returned for investigation.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 4 malfunction events.Questionable low elecsys ft3 iii results were generated by 2 e 411 immunoassay analyzers, two cobas e 602 module analyzers, and two cobas 6000 e 601 module analyzers the events involved four patient samples.Three patients' ages ranged between 48 and 71 years.The remaining patient's age was requested, but not provided.The patients' weights were requested, but not provided.There were three females.The remaining patient's age was requested, but not provided.The patients' races were requested, but not provided.The patients' ethnicities were requested, but not provided.

Manufacturer Narrative

For the pending event, the investigation could not identify a product problem.The cause of the event could not be determined.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 events.

• Brand Name: ELECSYS FT3 III
• Type of Device: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 9641135
• MDR Text Key: 199239522
• Report Number: 1823260-2020-90039
• Device Sequence Number: 1
• Product Code: CDP
• 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

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FT3 G3
• Device Lot Number: ASKU, 396459
• Patient Sequence Number: 1