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

Model Number	T3
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For 1 event, the investigation is ongoing.The follow up action for 1 event was that the sample was requested for investigation.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction event.Questionable high results were generated by the elecsys t3 assay on a cobas 8000 e 602 module.The events involved a total of 1 patient with the following: questionable t3 results the patient was "approximately (b)(6) years".
Additional Manufacturer Narrative
For the pending event, the patient's sample was provided for investigation.The investigation reproduced and confirmed the customer's t3 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 T3
• Common Device Name: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis, in
• MDR Report Key: 10332035
• Report Number: 1823260-2020-90118
• Device Sequence Number: 2004706
• Product Code: CDP
• UDI-Device Identifier: 04015630899937
• UDI-Public: 04015630899937
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• 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
• Operator of Device: No Information
• Device Model Number: T3
• Device Catalogue Number: 11731360122
• Device Lot Number: 39501800
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 10/22/2020
• Patient Sequence Number: 1