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

Model Number FT4 G3

Device Problem Non Reproducible Results (4029)

Patient Problem Test Result (2695)

Event Type  malfunction  

Manufacturer Narrative

Lot numbers continued: 426281,413768, asku.For 1 of the events, the investigation could not identify a product problem.The cause of the event could not be determined.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.There were no follow up actions.For 1 of the events, the investigation found 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.There were no follow up actions.For 1 of the events, the investigation did not identify a product problem.The cause of the event could not be determined.There were no follow up actions.For 1 of the events, the investigation could not identify a product problem.The cause of the event could not be determined.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.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 4 malfunction events.Questionable non-reproducible elecsys ft4 iii assay results were generated by two cobas e 411 immunoassay analyzers, two cobas 8000 e 602 modules, a cobas e 801 module, and a cobas 6000 e 601 module.The events involved a total of 4 patients.The patients' ages ranged from 13 to 94 years.The patients' weights were requested but were not provided.The patients were all female.The patients' races were requested but were not provided.The patients' ethnicities were requested but were not provided.

• Brand Name: ELECSYS FT4 III 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: 9990992
• MDR Text Key: 220816350
• Report Number: 1823260-2020-90073
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 07613336153956
• UDI-Public: 7613336153956
• Combination Product (y/n): N
• Number of Events Reported: 4
• 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

• 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: 426281, ASKU,
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2020
• Type of Device Usage: N
• Patient Sequence Number: 1