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
Event or Problem Description
1.Describe the event: the initial reporter questioned the results for 2 patient samples tested with elecsys ft4 iv on a cobas e 801 analytical unit.2.Patient age range: 76 year, 1 asku.3.Patient weight range: asku.4.Patient sex breakdown: asku.5.Patient race breakdown: asku.6.Patient ethnicity breakdown: asku.
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.3.Device returned to manufacturer? no.4.Device labeled "for single use?" no.5.Device reprocessed and reused? no.For one event: 1.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.2.Summary of follow up/corrective actions taken: the sample was requested for investigation, but the sample was not available for investigation.3.Device returned to manufacturer? no.4.Device labeled "for single use?"? no.5.Device reprocessed and reused? no.
Additional Manufacturer Narrative
For one event: 1.Summary of investigation results: investigations performed with the patient's sample did not confirm any interfering factors present in the sample.The differences in the values generated with different assays from roche diagnostics and the competitors¿ methods relate to differences of the setups of the assays, the antibodies used, differences in the standardization materials, and differences in the standardization procedures used.These differences also apply to the recovery in relation to the respective assay reference ranges.2.Summary of follow up/corrective actions taken: a sample from the patient was provided for investigation.3.Device returned to manufacturer? no.4.Device labeled "for single use?" no.5.Device reprocessed and reused? no.

• 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: 21925235
• Report Number: 1823260-2025-01321
• Device Sequence Number: 19848381
• 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: 2
• 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): 07/22/2025

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
• Device Lot Number: 820380, 82038002
• 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: 07/22/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/22/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown