MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T3; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Model Number T3

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.The device was not returned for investigation.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event.Questionable high elecsys t3 results were generated by a cobas 6000 e601 module.The event involved one patient sample.The patient's age was requested, but not provided.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, investigation of the patient sample found an interference to streptavidin and an immunoglobulin that reacts with the reagent which affects the sample results.This interference is documented in product labeling for the assay: 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.

• Brand Name: ELECSYS T3
• Type of Device: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 9638531
• MDR Text Key: 219514280
• Report Number: 1823260-2020-90034
• Device Sequence Number: 1
• Product Code: CDP
• UDI-Device Identifier: 04015630899937
• UDI-Public: 04015630899937
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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: T3
• Device Catalogue Number: 11731360122
• Device Lot Number: ASKU
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2020
• Patient Sequence Number: 1