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 Test Result (2695)

Event Type  malfunction  

Manufacturer Narrative

For 1 of the events, the investigation could not identify a product problem.The cause of the event could not be determined.The follow up actions were: the reagent pack was exchanged with a new one and the new pack was calibrated.For 1 of the events, the investigation did not identify a product problem as no sample from the patient could be provided.The cause of the event could not be determined.From the provided information, a general reagent issue could most likely be excluded.There were no follow up actions.The reported event involved an automated analytical device which is serviced in the field and not routinely returned for investigation.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 2 malfunction events.Questionable high elecsys ft4 ii assay results were generated by a cobas 8000 e 801 module and a cobas 6000 e 601 module.The events involved a total of 2 patients.The known patient's age was (b)(6).The other patient's age was requested but was not provided.The patients' weights were requested but were not provided.The known patient was male.The other patient's gender was requested but was not provided.The patients' races were requested but were not provided.The patients' ethnicities were requested but were not provided.

• Brand Name: ELECSYS FT4 II ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis, in
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; mannheim (baden-wurttemberg), 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; indianapolis, in
• MDR Report Key: 9990993
• MDR Text Key: 220813155
• Report Number: 1823260-2020-90072
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 04015630939725
• UDI-Public: 04015630939725
• Combination Product (y/n): N
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FT4 G2
• Device Catalogue Number: 07027397190
• Device Lot Number: 42917600,ASKU
• Type of Device Usage: N
• Patient Sequence Number: 1