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

The investigations found: for 5 events: 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/methods, and differences in the standardization methodology used.The investigation did not identify a product problem.The cause of the event could not be determined.For 1 event: 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 event: 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 3 events: the investigation is ongoing.The follow up/corrective actions were: for 4 events: the sample was either submitted or requested for further investigation.For 3 events: there was no follow up/corrective actions.For 3 events: the follow up/corrective actions are yet to be determined.For reagents: no devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 10 malfunction events.Erroneous high results were generated for elecsys ft3 iii.The events involved a total of 10 patients that were tested on the following instruments: 1 patient tested on a cobas 6000 e 601 module compared to the architect method.1 patient tested on a cobas e 411 immunoassay analyzer.3 patients tested on a cobas 8000 e 602 module.1 patient tested on a cobas 6000 e 601 module compared to an investigation sites cobas 8000 e602 module and an abbott architect.1 patient tested on an elecsys e170 modular analytics immunoassay analyzer.1 patient tested on a cobas e 411 immunoassay analyzer compared to the abbott architect method.1 patient tested on a cobas 8000 e 602 module compared to the centaur method.1 patient tested on a cobas 8000 e 602 module and a cobas 6000 e 601 module used for investigation.The provided patients' ages ranged from 9 days to 53 years.There were 4 females.

Manufacturer Narrative

For two of the pending events, the investigation determined that the patient sample contained an interferent to a component of the elecsys ft3 assay.This limitation is covered in product labeling.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 the one event, 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 FT3 III
• Type of Device: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8549718
• MDR Text Key: 143452980
• Report Number: 1823260-2019-90112
• Device Sequence Number: 1
• Product Code: CDP
• Combination Product (y/n): N
• Number of Events Reported: 10
• 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

• Device Operator: No Information
• Device Model Number: FT3 G3
• Device Lot Number: 1 = 34168500, 9 = ASKU
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2019
• Patient Sequence Number: 1