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	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys ft4 iii, elecsys ft4 iv and elecsys ft3 iii ver.2 results from one patient sample tested on the customer's cobas e 801 module with serial number (b)(6) and the investigation site's cobas e 801 module with serial number (b)(6).This mdr is for the ft3 iii v2 assay.Refer to: medwatch with a1 - patient identifier (b)(6) for the ft4 iv assay.Medwatch with a1 - patient identifier (b)(6) for the ft4 iii assay.The date the information was received was used as the date of the event.The initial results were reported outside of the laboratory.The physician requested that the sample be sent to the investigation site.The patient sample was then sent to the investigation site that uses a cobas e 801.It was also sent to an outsourced laboratory that uses a fujirebio lumipulse analyzer.Please refer to the attachment in the medwatch (b)(6) for the highlighted questionable results.
Additional Manufacturer Narrative
The ft3 iii v2 reagent lot number used at the customer site's e 801 was requested but not provided.The ft3 iii v2 reagent lot number used at the investigation site's e 801 is 669112 with an expiration date of 28-feb-2024.An interfering factor against the idiotype of the monoclonal antibody of the ft3iii assay was detected from a previous sample from this patient.The customer requested an analysis of the reported patient sample.The patient sample was requested for investigation.
Additional Manufacturer Narrative
The patient sample was received for investigation.The investigation obtained ft3 iii, ft4 iii, and ft4 iv assay results that were higher than the reference range.The patient sample was tested for interfering factors.The investigation detected an interfering factor against the ruthenium (ru) label of the ft4 iv and ft3 iii assays.Product labeling states "in rare cases, interference due to extremely high titers of antibodies toanalyte-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: 17356037
• Report Number: 1823260-2023-02347
• Device Sequence Number: 6016375
• 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): 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): 09/22/2023

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 Model Number: FT3 III
• Device Catalogue Number: 09005803190
• Device Lot Number: ASKU, 669112
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 09/22/2023
• 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