MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT3 III; RADIOIMMUNOASSAY, 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
For one event: 1.Summary of investigation results: the investigation is ongoing.2.Summary of follow up/corrective actions taken: the investigation is ongoing.For four events: 1.Summary of investigation results: sample from the patient was requested for investigation.2.Summary of follow up/corrective actions taken: the investigation is ongoing.For all 5 events: 3.Device returned to manufacturer? no, 4.Device labeled "for single use?" no, 5.Device reprocessed and reused? no.
Event or Problem Description
1.There was an allegation of questionable ft3 g3 elecsys e2g results for 1 patient from the cobas 8000 core unit, 2 patients from cobas 8000 - cobas e 602 modules, and 2 patients from cobas e 801 analytical units.2.Patient age range: 37-85 years, 3-asku, 3.Patient weight range: 5-asku, 4.Patient sex breakdown: 2-female, 3-asku, 5.Patient race breakdown: 5-asku, 6.Patient ethnicity breakdown: 5-asku.
Additional Manufacturer Narrative
For one of the pending events: 1.Summary of investigation results: the investigation determined the patient sample contained a streptavidin interfering factor.Per product labeling for the assay: 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.2.Summary of follow up/corrective actions taken: sample material from the patient was tested for investigation.For two of the pending events: 1.Summary of investigation results: the investigation found an interference to the suru label in the patient sample.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.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.There was no malfunction of the device or reagent.2.Summary of follow up/corrective actions taken: sample from the patient was tested for investigation.For one of the pending events: 1.Summary of investigation results: the customer's ft3 results were reproduced at the investigation site.Upon further investigation of the sample, an interfering factor against the idiotype of the monoclonal antibody of the reagent was identified.This interference caused the high results.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." a general reagent problem can be excluded.The investigation did not identify a product problem.2.Summary of follow up/corrective actions taken: the patient sample was submitted for investigation.For one of the pending events: 1.Summary of investigation results: upon further investigation of the sample, an interfering factor against the idiotype of the monoclonal antibody of the reagent was identified.This interference caused the high results.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." a general reagent problem can be excluded.The investigation did not identify a product problem.2.Summary of follow up/corrective actions taken: the patient sample was submitted for investigation.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21232797
• Report Number: 1823260-2025-00229
• Device Sequence Number: 20966859
• Product Code: CDP
• UDI-Device Identifier: 04015630939718
• UDI-Public: 04015630939718
• Combination Product (Y/N): N
• PMA/510(K) Number: K963127
• Exemption Number: VMSR
• Number of Events Summarized: 5
• 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): 04/17/2025

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
• Operator of Device: Health Professional
• Device Model Number: FT3 III
• Device Catalogue Number: 09165576001
• Device Lot Number: ASKU,801917, 777784
• Was Device Available for Evaluation?: Yes
• 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: 02/06/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 04/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown