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

Model Number	FT4 IV
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.Summary of investigation results: this 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.There was an allegation of questionable elecsys ft4 iv results for one patient from a cobas e 801 module analyzer.2.Patient age range: 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 the pending event: 1.Summary of investigation results: the investigation did not identify a product issue.A general product problem can be excluded.The differences generated between the different methods most likely relate to normal methodological differences.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.2.Summary of follow up/corrective actions taken: no additional follow up actions were taken.

• 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: 20535417
• Report Number: 1823260-2024-03095
• Device Sequence Number: 6697684
• Product Code: CEC
• UDI-Device Identifier: 07613336172780
• UDI-Public: 07613336172780
• Combination Product (Y/N): Y
• PMA/510(K) Number: K220456
• Exemption Number: VMSR
• Number of Events Summarized: 1
• 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): 10/30/2024

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?: No
• Device Model Number: FT4 IV
• Device Catalogue Number: 09043284190
• Device Lot Number: 788436
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 10/30/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown