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

Lot no continued: asku for 1 of the events, the customer stated that the patient result comparability between the cobas e601 and an abbott system was improved after performing preventative maintenance.As the patient sample was not available for further investigation, the specific cause of the event could not be determined.The investigation did not identify a product problem.For 2 of the events, the investigation is ongoing.For 1 of the events, from the information provided, a general reagent issue can be excluded.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials and the standardization methodology used.The investigation did not identify a product problem.For 1 of the events, an interfering factor could not be identified.The investigation did not identify a product problem.The cause of the event could not be determined.For 2 of the events, 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 differences in the standardization methodology used.For 1 of the events, preventative maintenance was performed on the analyzer.For 1 of the events, the sample was provided 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 7 malfunction events.Questionable high results were generated by a cobas 6000 e 601 module compared to an abbott, a cobas 8000 e 602 module, and a cobas 8000 e 602 module compared to an abbott system.The events involved a total of 7 patients with elecsys ft4 iii assay.The provided patients' ages ranged from 28 to "60s" years.The other patients' ages were requested but were not provided.The patients' weights were requested but were not provided.There were 2 females and 1 male.The other patients' genders were requested but were not provided.The patients' races were requested but were not provided.The patients' ethnicities were requested but were not provided.

Manufacturer Narrative

For one of the pending events, the investigation could not identify a product problem.The cause of the event could not be determined.There were no follow up actions for this event.For the one other pending event, sample form the patient was investigated.An interfering factor against sa could be excluded in this sample the investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 9238182
• MDR Text Key: 219401963
• Report Number: 1823260-2019-90250
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Number of Events Reported: 7
• 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 G3
• Device Lot Number: 391521, 410248
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2020
• Patient Sequence Number: 1