MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T4; TOTAL THYROXINE ASSAY

Model Number	T4
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.Summary of investigation results: the investigation was unable to determine a specific root cause.As no sample material was available, further investigation was not possible.2.Summary of follow-up/corrective actions taken: there were no follow-up/corrective actions.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 t4 results for one patient from the cobas e411 rack 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.

• Brand Name: ELECSYS T4
• Common Device Name: TOTAL THYROXINE ASSAY
• 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: 24183967
• Report Number: 1823260-2026-00283
• Device Sequence Number: 21336204
• Product Code: CDX
• UDI-Device Identifier: 07613336171660
• UDI-Public: 07613336171660
• 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): 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: 12/31/2025
• Device Model Number: T4
• Device Catalogue Number: 09007741190
• Device Lot Number: 80586805
• 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