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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 lot no continued: 82038002, 777784.For 4 of the events: summary of investigation results: the investigation is ongoing.Summary of follow-up/corrective actions taken: the patient sample was requested for investigation.For 1 of the events: summary of investigation results: the investigation is ongoing.Summary of follow-up/corrective actions taken: the investigation is ongoing.For 1 of the events: summary of investigation results: the investigation was unable to determine a root cause due to the sample not being available for investigation.The investigation could not identify a product problem.The cause of the event could not be determined.Summary of follow-up/corrective actions taken: the sample was requested for investigation, but the sample was not available for investigation.Device returned to manufacturer? no.Device labeled "for single use?" no.Device reprocessed and reused? no.
Event or Problem Description
1.Describe the event: there were allegations of discrepant high results for 6 patients tested for elecsys ft3 iii.The events involved 2 cobas 8000 e 801 modules, 2 cobas 8000 core units, a cobas 6000 e601 module, and a cobas e 602 module.2.Patient age range: 1 asku, 40 - 79 years.3.Patient weight range: 6 asku.4.Patient sex breakdown: 2 asku, 4 females.5.Patient race breakdown: 6 asku.6.Patient ethnicity breakdown: 6 asku.
Additional Manufacturer Narrative
For 3 of the events: 1.Summary of investigation results: the investigation determined that the event was due to the interferent in the patient sample.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.2.Summary of follow-up/corrective actions taken: the patient samples were submitted for investigation and were analyzed for interferents.Interferents to the assay antibody were detected in the patient samples.For 1 of the events: 1.Summary of investigation results: it was found that there were beads in the reagent lid, which suggests inadequate reagent storage conditions either during transport or storage at the customer site.The investigation determined the event was due to a reagent transport or storage issue.2.Summary of follow-up/corrective actions taken: the customer discarded the reagent kit.For 1 of the events: 1.Summary of investigation results: the investigation did not identify a product problem.Product labeling states "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." 2.Summary of follow-up/corrective actions taken: the patient samples were submitted for investigation and were analyzed for interferents.No interferent was detected in the patient sample.

• 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: 21925101
• Report Number: 1823260-2025-01308
• Device Sequence Number: 21014754
• Product Code: CDP
• UDI-Device Identifier: 07613336171578
• UDI-Public: 07613336171578
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Exemption Number: VMSR
• Number of Events Summarized: 6
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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?: No
• Device Model Number: FT3 III
• Device Catalogue Number: 09005811190
• Device Lot Number: ASKU, 80191700, 80191701
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/27/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown