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

Model Number FT3 G3

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

For four of the events, the investigation did not identify a product problem.The cause of the event could not be determined.The investigation found for one of the events all thyroid parameter results are in concordance in relation to the normal reference ranges of the respective methods.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials, and differences in the standardization methodology used.For one of the events, the investigation did not identify a product problem.The cause of the event could not be determined.To the mathematical differences of the tsh and ft4 and ft3 values generated with the analyzers from roche diagnostics and abbott: it needs to be taken into account that assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.For two of the events, the investigation is ongoing.The follow up/corrective actions for two of the events was the sample was requested for investigation.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 8 malfunction events.Questionable high results were generated by elecsys ft3 iii.The events involved a total of 12 patients with the following: 9 e 602 module, 4 e 601 module.The provided patients' ages ranged from 14 to 84 years.There were 4 females and 2 males.

Manufacturer Narrative

For one of the pending events, the investigation did not identify a product problem.The cause of the event could not be determined.The patient sample was requested for further investigation but was not available.There were no follow up activities for this event.For the other pending event, the investigation determined the patient sample contains an interferent to a component of the ft3 assay.This limitation is covered in product labeling.There were no follow up actions for this event.

• 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: 8830199
• MDR Text Key: 152670161
• Report Number: 1823260-2019-90200
• Device Sequence Number: 1
• Product Code: CDP
• Combination Product (y/n): N
• Number of Events Reported: 8
• 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: FT3 G3
• Device Lot Number: ASKU, 372451
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/22/2019
• Patient Sequence Number: 1