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

For 1 event, the investigation did not identify a product problem.The cause of the event could not be determined.Results generated with the different analyzers from different manufacturers, are caused by differences of the setups of the assays, the antibodies used and differences of the standardization materials and procedures used.For 1 event, a general reagent issue can be excluded as the quality validation data provided was within expectations.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 action for 1 event was that the sample from the patient was submitted for investigation.The follow up action for 1 event was that the sample was requested for investigation but could not be provided.The follow up action for 1 event was that the sample from the patient was submitted for investigation.No interference could be identified.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 3 malfunction events.Questionable high results were generated by the elecsys ft3 iii on 2 cobas 6000 e601 modules and 1 cobas e411 analyzer.The events involved a total of 3 patients.The patients' ages ranged from "teenager" to 70 years.The other patient's age was requested but was not provided.The patient weight was (b)(6).The other patients' weights were requested but were not provided.There were 2 females and 1 male.The patients' races were requested but were not provided.The patients' ethnicities were requested but were not provided.

Manufacturer Narrative

For the one pending event, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FT3 III
• Type of Device: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis, in
• MDR Report Key: 9996211
• MDR Text Key: 213910190
• Report Number: 1823260-2020-90071
• Device Sequence Number: 1
• Product Code: CDP
• Combination Product (y/n): N
• Number of Events Reported: 3
• 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: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FT3 G3
• Device Lot Number: ASKU, 425531
• Patient Sequence Number: 1