MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT3 III; TOTAL TRIIODOTHYRONINE

Model Number	FT3 III
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.Summary of investigation results: as the sample was not available, the cause of the event could not be determined.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 sample was requested for investigation; however, no sample material is available for further testing.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 was an allegation of questionable results for 1 patient tested for elecsys ft3 iii on a cobas e 801 analytical unit compared to the mindray method.2.Patient age range: 11 years 3.Patient weight range: asku 4.Patient sex breakdown: male 5.Patient race breakdown: asku.6.Patient ethnicity breakdown: asku.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 25002377
• Report Number: 1823260-2026-01648
• Device Sequence Number: 18613224
• 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: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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: 88587401
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown