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	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's e801 analyzer was requested but not provided.The serial number of e801 analyzer used for investigation is (b)(6).The serial number of e411 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 e801 was 669112 with an expiration number of 29-feb-2024 and the ft3 iii v2 reagent lot number used on cobas e411 was 686656 with an expiration date of 30-apr-2024.The ft4 iv reagent lot number and expiration date used at the customer's site were not provided.The ft4 iv reagent lot number used on cobas e801 was 724974 with an expiration number of 31-may-2024 and the ft4 iv reagent lot number used on cobas e411 was 724896 with an expiration date of 30-jun-2024.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials, and the standardization methodology used.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for 1 patient sample tested with elecsys ft3 g3 v2 (ft3 iii v2) assay and ft4 g4 (ft4 iv) assay on a cobas 8000 e801 module.The sample also had discrepant results when tested on another cobas 8000 e801 module and on a cobas e411 immunoassay analyzer.This medwatch will apply to the ft3 iii v2 assay.Please refer to the medwatch with a1.Patient identifier pt (b)(6) for information related to the ft4 iv assay.Refer to the attachment for all patient data.The sample was initially tested and repeated on the customer's e801 analyzer on (b)(6) 2024.The sample was provided for investigation where it was tested on a 2nd e801 analyzer and e411 analyzer on (b)(6)2024.The sample was also repeated on an abbott architect analyzer on (b)(6) 2024.
Additional Manufacturer Narrative
Section b3 was updated.The sample was requested but not provided for investigation.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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18959117
• Report Number: 1823260-2024-00860
• Device Sequence Number: 15813883
• 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): 04/15/2024

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: 02/26/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 04/15/2024
• 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