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

Model Number	FT3 III
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient sample was received for investigation.
Event or Problem Description
The initial reporter received questionable elecsys ft4 iii assay, elecsys ft3 iii and elecsys ft3 iii ver.2, and elecsys anti-tshr immunoassay ver.2 results for one patient sample tested on the customer's cobas e411 rack with serial number (b)(4), the investigation site's cobas 8000 e 411 module with serial number (b)(4).This mdr is for the ft3 iii v2 assay.Refer to: medwatch with patient identifier (b)(6) for the ft3 iii assay.Medwatch with patient identifier (b)(6) for the anti-tshr assay.Medwatch with patient identifier (b)(6) for the ft4 iii assay.The initial result was not reported outside of the laboratory.The reporter suspected non-specific interference in the roche thyroid assays.The patient sample was sent to the investigation site and an outsourced laboratory that uses a fujirebio lumipulse analyzer.The ft3 iii v2 reagent lot used in the customer site's e 411 and its expiration date were requested but not provided.The ft3 iii v2 reagent lot used in the investigator site's e 411 is 567499 with an expiration date of 30-nov-2022.Refer to the attachment in the medwatch for the highlighted questionable results.
Additional Manufacturer Narrative
The patient sample was received for investigation.The investigation confirmed the high ft4 and ft3 and anti-tshr results obtained by the customer.The results of the different test versions were comparable.The ft4 iii and ft4 iv concentration values were both above the reference range but these values clearly showed differences.The investigation determined an interfering factor against ruthenium (ru) label in the ft3 and ft4 assays.The same interfering factor most likely also caused the falsely elevated value of the anti-tshr assay.A combination of an interfering factor against ft3 antibody/idiotype was also observed in the patient sample.Product labeling states "in rare cases, interference due to extremely high titers of antibodies to test 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.

• Brand Name: ELECSYS FT3 III
• Common Device Name: 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: 16033932
• Report Number: 1823260-2022-04151
• Device Sequence Number: 5476536
• Product Code: CDP
• UDI-Device Identifier: 07613336171585
• UDI-Public: 07613336171585
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 03/02/2023

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 Model Number: FT3 III
• Device Catalogue Number: 09005803190
• Device Lot Number: ASKU, 567499
• 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: 11/28/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 03/02/2023
• 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