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

Model Number	FT3 III
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for 2 patients' samples tested with elecsys ft3 g3 v2 (ft3 iii v2) assay on a cobas 8000 e801 module.The samples also had discrepant results when tested on another cobas 8000 e801 module and a cobas e411 immunoassay analyzer.Refer to the attachment for the patients' data.Sample 1 was initially tested on the customer's e801 module on (b)(6) 2024 and sample 2 was initially tested on the customer's e801 module on (b)(6) 2024.The samples were provided for investigation where they tested on an e411 analyzer on (b)(6) 2024 and a 2nd e801 module on (b)(6) 2024.The samples were also repeated on an abbott architect analyzer on (b)(6) 2024.
Additional Manufacturer Narrative
The serial number of the customer's e801 analyzer was requested but not provided.The serial number of e411 analyzer used for investigation is (b)(6).The serial number of e801 analyzer used for investigation is (b)(6).The ft3 iii v2 reagent expiration date used at the customer's site was not provided.The ft3 iii v2 reagent lot number used on cobas e411 was 686656 with an expiration date of 30-apr-2024.The ft3 iii v2 reagent lot number used on cobas e801 was 669112 with an expiration date of 29-feb-2024.The 2 samples were provided for investigation on 06-mar-2024.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation of both samples detected assay-interfering factors causing the falsely elevated values of the ft3 iii assay.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 did not identify a product problem.The root cause was due to interfering factors detected in the samples.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18870596
• Report Number: 1823260-2024-00717
• Device Sequence Number: 14205373
• Product Code: CDP
• UDI-Device Identifier: 07613336171578
• UDI-Public: 07613336171578
• Combination Product (Y/N): Y
• 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): 05/15/2024

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: 09005811190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 05/15/2024
• 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