MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T3; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Model Number	T3
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 1 event: 1.Summary of investigation results: the investigation did not identify a product problem.2.Summary of follow-up/corrective actions taken: the patient sample is not available for investigation.For 1 event: 1.Summary of investigation results: the investigation did 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 received for investigation.Interference testing was performed; no interference affecting the t3 results was identified.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.For 2 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.Describe the event: there was an allegation of questionable elecsys t3 results for 2 patient samples tested on cobas e 801 analytical units.2.Patient age range: 4-66 years.3.Patient weight range: asku.4.Patient sex breakdown: 2-male.5.Patient race breakdown: 1-asku, 1-asian.6.Patient ethnicity breakdown: 1-asku, 1-non-hispanic/latino.

• Brand Name: ELECSYS T3
• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24183968
• Report Number: 1823260-2026-00280
• Device Sequence Number: 13265959
• Product Code: CDP
• UDI-Device Identifier: 07613336171653
• UDI-Public: 07613336171653
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 01/26/2026

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 Expiration Date: 03/31/2026
• Device Model Number: T3
• Device Catalogue Number: 09007733190
• Device Lot Number: 838223
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown