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	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for 4 patient samples tested with the elecsys tsh, the elecsys ft4 iii, and the elecsys ft3 iii ver.2 (ft3 v2) assay on multiple roche analyzers and compared to the abbott architect method.The questionable results were reported outside of the laboratory.This medwatch will apply to the ft3 v2 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the tsh assay and to the medwatch with patient identifier (b)(6) for information related to the ft4 iii assay.The samples were initially tested with tsh, ft4 iii, and ft3 v2 on the customer's cobas e 801 module on an unknown date.The samples were provided for investigation, where they were tested with the tsh, ft4 iii, and ft3 v2 assays on a second e 801 module on (b)(6) 2023.During investigations, the samples were also tested with the tsh, ft4 iii and ft3 v2 assays on a cobas e 411 analyzer on (b)(6) 2023.The samples were also repeated using the abbott architect tsh, ft4 and ft3 methods on (b)(6) 2023.Refer to the attachment for all relevant test data.The serial number of the customer's e 801 analyzer was requested but not provided.The serial number of the e 801 analyzer used for investigation is (b)(4).Ft3 v2 reagent lot number 611920, with an expiration date of 31-may-2023 was used on this analyzer.The serial number of the e411 analyzer used for investigation is (b)(4).Ft3 v2 reagent lot number 611918, with an expiration date of 30-may -2023 was used on this analyzer.
Additional Manufacturer Narrative
The investigation could not identify a product problem.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.

• 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: 16575790
• Report Number: 1823260-2023-00890
• Device Sequence Number: 12557625
• 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
• Report Date (Section B): 03/20/2023

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: 611920, 611918
• 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: 02/21/2023
• Initial Report FDA Received Date: 03/20/2023
• 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