MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T4 ASSAY; RADIOIMMUNOASSAY, TOTAL THYROXINE

Model Number T4

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation of the event is currently ongoing.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event.Questionable high results were generated for the elecsys t4 assay on a cobas 8000 e 602 module.The event involved one patient sample.The patients' age was "approximately 50 years".The patient's weight was requested, but not provided.The patient is male.The patient's race was requested, but not provided.The patient's ethnicity was requested, but not provided.

Manufacturer Narrative

For the pending event, the patient's sample was provided for investigation.The investigation reproduced and confirmed the customer's t4 result.An interfering factor against a component of the reagent was identified.The interfering factor was streptavidin.Per labeling, "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings." the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS T4 ASSAY
• Type of Device: RADIOIMMUNOASSAY, TOTAL THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis, in
• MDR Report Key: 10331934
• MDR Text Key: 202524210
• Report Number: 1823260-2020-90119
• Device Sequence Number: 1
• Product Code: CDX
• UDI-Device Identifier: 04015630912728
• UDI-Public: 04015630912728
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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: T4
• Device Catalogue Number: 12017709122
• Device Lot Number: 38326800, 41543400
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/22/2020
• Patient Sequence Number: 1