MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 II ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE

Model Number FT4 G2

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

Lot numbers: 5 = 336701, and 8 = asku.The investigations found: for 8 events: 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.The investigation did not identify a product problem.The cause of the event could not be determined.For 5 events: the investigation could not identify a product problem.The cause of the event could not be determined.For 1 event: 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 2 events: the investigation is currently ongoing.The follow up/corrective actions were: for 1 event: no patient sample remained for further investigation.For 6 events: there was no follow up/corrective action.For 5 events: the patient sample was submitted/requested for investigation.For 1 event: the sample was also tested on a cobas e 601 module to demonstrate reproducibility.For 1 event: the sample was submitted for preliminary investigation and tested on an e411 analyzer and the centaur method.For 2 events: the follow up/corrective action has yet to be determined.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 16 malfunction events.Erroneous high results were generated for elecsys ft4 ii assay.The events involved a total of 20 patients that were tested on the following instruments: 1 patient tested on a cobas 6000 e 601 module compared to a centaur analyzer.3 patients tested on a cobas e 411 immunoassay analyzer.1 patient tested on a cobas 6000 e 601 module compared to an investigation sites cobas 8000 e602 module and an abbott architect.2 patients tested on a cobas 8000 e 801 module.2 patients tested on a cobas 6000 e 601 module.8 patients tested on a cobas 8000 e 602 module.1 patient tested on a elecsys e170 modular analytics immunoassay analyzer.1 patient tested on a cobas 6000 e 601 module compared to the beckman coulter.1 patient tested on a cobas 8000 e 602 module compared to the centaur method.For 15 patients, the patients' ages ranged from 9 days to 82 years.There were 8 females and 6 males.

Manufacturer Narrative

For one of the pending events, the investigation determined that the patient sample contained an interferent to a component of the elecsys ft4 ii assay.This limitation is covered in product labeling.For the other pending event, the investigation could not identify a product problem.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 II ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8549732
• MDR Text Key: 143693726
• Report Number: 1823260-2019-90132
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Number of Events Reported: 16
• 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: FT4 G2
• Device Lot Number: 277931, 315901, 361887
• 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