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	02/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's e801 analyzer is (b)(6).The ft3 reagent lot number and expiration date used on this analyzer were requested, but not provided.The serial number of the e801 analyzer used for investigation is (b)(6).Ft3 reagent lot number 737314, with an expiration date of 30-nov-2024 was used on this analyzer.The serial number of the e411 analyzer used for investigation is (b)(6).Ft3 reagent lot number 686656, with an expiration date of 30-apr-2024 was used on this analyzer.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys ft3 iii on two cobas e 801 module analyzers and a cobas e 411 analyzer.Refer to the attachment for all patient data.The sample was initially tested on the customer's e801 analyzer on (b)(6)2024.The sample was repeated using the wako accuraseed and abbott alinity methods.The sample was also treated with a 25% polyethylene glycol (peg) solution and repeated on the e801 analyzer.The sample was provided for investigation, where it was tested on a second e801 analyzer and an e411 analyzer on (b)(6) 2024.
Additional Manufacturer Narrative
The customer has clarified that the affected sample is another sample from the same patient previously reported in mfg report numbers 1823260-2023-00722 and 1823260-2023-00723.Further investigations performed with the affected patient sample determined that it contains an interfering factor against the ruthenium label component of the ft3 assay.Per product labeling: "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." the investigation did not identify a product issue.

• 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: 18985248
• Report Number: 1823260-2024-00920
• Device Sequence Number: 18238104
• 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): 06/17/2024

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, 737314, 686656
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 58 YR
• Patient Sex: Male