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	01/27/2023
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 ver.2 (ft3 iii v 2) on two cobas e 801 modules.The sample also had discrepant results for elecsys ft3 iii (ft3 iii) when tested on the second e 801 module that was used for investigation.No questionable results were reported outside of the laboratory.This medwatch will apply to the ft3 iii assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 iii v 2 assay.Refer to the attachment for all patient data.Questioned values are highlighted in yellow.The sample was initially tested with the ft3 ii v 2 assay when tested on the customer's e 801 module on (b)(6) 2023.The sample was repeated by the customer using the wako accuraseed ft3 method.The customer also treated the sample with polyethylene glycol (peg) and repeated it on their e 801 module.The sample was provided for investigation where it was tested with ft3 iii and ft3 iii v 2 on a second e 801 analyzer on (b)(6) 2023.The sample was also repeated using the abbott architect ft3 method on (b)(6) 2023.The serial number of the customer's e 801 module is (b)(4).Ft3 iii was not tested on this analyzer.The serial number of the e 801 module is (b)(4).Ft3 iii reagent lot number 630888, with an expiration date of 31-may-2023 was used on this analyzer.
Additional Manufacturer Narrative
Further investigations of the patient sample determined that it does not contain an interfering factor against the streptavidin component of the ft3 iii/ft3 iii v 2 assays.The sample contained an interfering factor against the idiotype of the monoclonal antibody used in the ft3 iii assay.Per product 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".

• 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: 16308222
• Report Number: 1823260-2023-00365
• Device Sequence Number: 6792430
• 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): 04/10/2023

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: 05/31/2023
• Device Model Number: FT3 G3
• Device Catalogue Number: 07027362190
• Device Lot Number: 630888
• 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: 01/16/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 04/10/2023
• 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 Age: 43 YR
• Patient Sex: Male