MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 IV; FREE THYROXINE

Model Number	FT4 IV
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 2 of the events: 1.Summary of investigation results: the investigation is ongoing.2.Summary of follow up/corrective actions taken: sample from the patient was requested for investigation.For 1 of the events: 1.Summary of investigation results: the investigation is ongoing.2.Summary of follow up/corrective actions taken: the investigation is ongoing.3.Device returned to manufacturer? no.4.Device labeled "for single use?" no.5.Device reprocessed and reused? no.
Event or Problem Description
1.Describe the event: there were allegations of questionable high results for 3 patient samples tested for elecsys ft4 iv on 1 cobas e801 analytical unit and 2 cobas 8000 e 602 modules.2.Patient age range: one 85 years, 2 asku.3.Patient weight range: asku.4.Patient sex breakdown: 1 female, 2 asku.5.Patient race breakdown: asku.6.Patient ethnicity breakdown: asku.
Additional Manufacturer Narrative
For one of the events: summary of investigation results: the investigation did not a product problem.The cause of the event was consistent with a pre-analytical issue (a clot was detected in the sample) at the customer's site.Pre-analytical is within the customer's responsibility.Summary of follow up/corrective actions taken: the analyzer was checked and no problem was found.For two of the events: 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.Summary of follow up/corrective actions taken: sample from the patient was tested for investigation.

• Brand Name: ELECSYS FT4 IV
• Common Device Name: FREE THYROXINE
• 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: 21266840
• Report Number: 1823260-2025-00271
• Device Sequence Number: 15565983
• Product Code: CEC
• UDI-Device Identifier: 07613336172780
• UDI-Public: 07613336172780
• Combination Product (Y/N): N
• PMA/510(K) Number: K220456
• Exemption Number: VMSR
• Number of Events Summarized: 3
• 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
• Device Model Number: FT4 IV
• Device Catalogue Number: 09043284190, 09043276190
• Device Lot Number: 79774401, 784368, ASKU
• 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: 01/27/2025
• Initial Report FDA Received Date: 01/29/2025
• 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