MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT3 III; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Model Number	FT3 G3
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys ft3 iii v2 assay (ft3 v2) on 2 cobas 8000 e 801 modules and a cobas e 411 immunoassay analyzer.The sample also had discrepant result for the elecsys ft3 iii (ft3) assay on one of the two e 801 modules.The specific date of the event is unknown.This medwatch will apply to the ft3 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 v2 assay.Refer to the attachment for all patient data.The sample was initially tested on the customer's e 801 analyzer.The sample was the provided for investigation where it was tested on a 2nd e 801 analyzer and e 411 analyzer on 30-nov-2022.The sample was also repeated on an abbott architect analyzer on 6-dec-2022.The serial number of the customer's e 801 analyzer was requested but not provided.The serial number of e 801 analyzer used for investigation is 14d9-06.The ft3 reagent lot number was 583301 with an expiration date of 28-feb-2023.The serial number of e 411 analyzer used for investigation is (b)(4).
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
Sections d9, h3 and imdrf codes were updated.1 sample was provided for investigation.An interfering factor against streptavidin agent could be identified in this sample, as changing signal values were observed for the a-tg v1 vs.A-tg v2 reagent.Customer¿s values for ft3 iii and ft4 3 were reproduced.An influence of prewash could be observed for the ft3 iii v1 assays.The rarely occurring event of the detected interfering factor is covered by a disclaimer in the section limitation - interference in the method sheets of all applicable products: 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.A product problem could not be found.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.

• Brand Name: ELECSYS FT3 III
• Common Device Name: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16016817
• Report Number: 1823260-2022-04114
• Device Sequence Number: 20477400
• Product Code: CDP
• UDI-Device Identifier: 04015630939718
• UDI-Public: 04015630939718
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: FT3 G3
• Device Catalogue Number: 07027362190
• Device Lot Number: 583301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown