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	10/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer performed a tsh dilution test and noted that the results had good linearity.The customer also performed polyethylene glycol (peg) treatment tests.The customer stated that the ft3 recovery rate decreased after 25% peg treatment, while the tsh and ft4 recovery rates did not decrease after 25% peg treatment.The patient sample was requested for investigation.
Event or Problem Description
The initial reporter received questionable elecsys elecsys ft3 iii and elecsys ft3 iii ver.2 results from one patient sample tested on the customer's cobas e 801 module with serial number (b)(4), the investigation site's cobas e 801 module with serial number (b)(4) and the investigation site's e 411 analyzer with serial number (b)(4).This mdr is for the ft3 iii assay.Refer to medwatch with patient identifier (b)(6) for the ft3 iii v2 assay.The initial results were not reported outside of the laboratory.The reporter suspected some nonspecific interference in the roche assays.The patient samples were then sent to an investigation site that uses an e 411 and an e 801.It was also sent to an outsourced laboratory that uses an abbott architect.The ft3 iii reagent lot number used at the investigation site's e 411 is 585947 with an expiration date of 28-feb-2023.The ft3 iii reagent lot number used at the investigation site's e 801 is 583301 with an expiration date of 28-feb-2023.Refer to the attachment in the medwatch for the highlighted questionable results.
Additional Manufacturer Narrative
Upon further investigation of the patient sample, an interferent against the biotinol component of the reagent was confirmed.Product labeling states "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.".
Additional Manufacturer Narrative
The patient sample was received for investigation.The investigation was able to reproduce the customer's ft3 result.Upon further investigation of the patient sample, an interferent against the streptavidin component of the reagent was confirmed.Product labeling states "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 is ongoing.

• 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: 16356285
• Report Number: 1823260-2023-00425
• Device Sequence Number: 6432464
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2023

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: 585947, 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: 01/16/2023
• Supplement Date Received by Manufacturer: 03/30/2023; 05/17/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 04/26/2023; 06/09/2023
• 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: 69 YR
• Patient Sex: Female