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

Model Number	T4
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); Low Readings (2460)
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 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.Describe the event: there was an allegation about questionable high results for 1 patient tested for elecsys t4 on a cobas 6000 e601 module.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
1.Summary of investigation results: the investigation determined that the issue was related to maintenance.The cause of the event was due to failing pinch valves, a bent reagent probe, and a low voltage on the probe (component failure).2.Summary of follow-up/corrective actions taken: the field service engineer replaced the pinch valves, the reagent and the sample probes.

• 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: 22587462
• Report Number: 1823260-2025-02269
• Device Sequence Number: 15787975
• 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,Followup
• Report Date (Section B): 08/28/2025

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 Expiration Date: 12/31/2025
• Device Model Number: T4
• Device Catalogue Number: 09007741190
• Device Lot Number: 805868
• 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: 07/31/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/28/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown