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 numbers continued: asku, 39152100, asku, asku, asku, asku, asku.For 6 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.The investigation could not identify a product problem.The cause of the event could not be determined.For 1 event, there was insufficient sample material remaining for investigation.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 event, 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 event, there was insufficient sample material remaining for investigation.Assays from different vendors can generate different values.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 event, the investigation is ongoing.The follow up actions for 2 events was that the samples were requested for investigation but sufficient sample material could not be provided.The follow up actions for 1 event was that the sample was requested for investigation but could not be provided.There were no follow up actions for 7 events.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.High results were generated by the elecsys ft4 iii assay on 3 cobas 6000 e 601 modules, 7 cobas 8000 e 602 modules and 1 cobas e411 rack analyzer.The events involved a total of 13 patients.The patients' ages ranged from 27 to 84 years.There were 2 males and 4 females.

Manufacturer Narrative

For the one pending event, 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.

• 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: 8830194
• MDR Text Key: 152669165
• Report Number: 1823260-2019-90198
• Device Sequence Number: 1
• Product Code: CEC
• 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

• 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: 378826, ASKU, ASKU
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/21/2019
• Patient Sequence Number: 1