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

The investigations found for 1 of the events that a general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.Assays from different manufacturers, in this case abbott, can generate different results.This relates to the overall set up of the assays, the antibodies used and differences in reference materials and the standardization methodology used.The investigations found for 1 of the events that different assays from different vendors can generate different values.This is related to the overall setups of the assays, the antibodies used, differences in reference materials, and differences in the standardization methodology used.The normal reference ranges can equally be different as related to the population used and the calculation mode.A higher bias with the ft4 assay may also be caused by an aged measuring cell as higher than expected calibration signals were observed.For 3 of the events, a general reagent issue can be excluded.Assays from different manufacturers can generate different results.The investigation did not identify a product problem.The cause of the event could not be determined.For 1 of the events, a sample from the patient was submitted for investigation.No interfering factors were identified.The investigation did not identify a product problem.The cause of the event could not be determined.For 1 of the events, there was not enough sample volume left to complete the investigation.From the information available, a general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.For 1 of the events, the investigation did not identify a product problem.A general reagent issue most likely can be excluded.The cause of the event could not be determined.For 1 of the events, the investigation is ongoing.The follow up/corrective actions for 1 of the events was the sample was submitted for investigation.The follow up/corrective actions for 1 of the events was the measuring cell of the analyzer was replaced.The follow up/corrective actions for 5 of the events was the sample was requested for investigation.For reagent: no devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 9 malfunction events.Erroneous high results were generated by a cobas 6000 e 601 module, a cobas 8000 e 602 module, and an elecsys e170 modular analytics immunoassay analyzer.The events involved a total of 10 patients with elecsys ft4 iii.The provided patients' ages ranged from 9 days to 72.There were 2 females and 2 males.

Manufacturer Narrative

For the remaining pending event, the investigation did not identify a product problem.A general reagent issue could most likely be excluded.The cause of the event could not be determined.For one of the events where it was previously reported that the investigation did not identify a product problem, sample from the patient was submitted for investigation.The biotin concentration was found to be far above the allowable threshold concentration specified in product labeling for the assays.This high biotin concentration most likely caused event.There was no malfunction of the device.

• 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: 8556085
• MDR Text Key: 143418917
• Report Number: 1823260-2019-90158
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Number of Events Reported: 9
• 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: 04/26/2019
• Device Operator: No Information
• Device Model Number: FT4 G3
• Device Lot Number: ASKU, 331797
• Patient Sequence Number: 1