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

Model Number	T4
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 one of the events: 1.Summary of investigation results: the investigation found an issue with the specific reagent pack.No general reagent problem was found.2.Summary of follow up/corrective actions taken: calibration and qc were reviewed and acceptable.For one of the events: 1.Summary of investigation results: this investigation is ongoing.2.Summary of follow up/corrective actions taken: the investigation is ongoing.For one of the events: 1.Summary of investigation results: the investigation is ongoing.2.Summary of follow up/corrective actions taken: the samples were requested for investigation.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 22 patients for elecsys t4 from three cobas e 801 module analyzers.2.Patient age range: 3 are 3 - 72 years, 19 are asku.3.Patient weight range: asku.4.Patient sex breakdown: 1 female, 1 male, 20 asku.5.Patient race breakdown: 2 asian, 20 asku.6.Patient ethnicity breakdown: asku.
Additional Manufacturer Narrative
For one of the events: summary of investigation results: this investigation determined the issue is related to the reagent pack.The pack was either subjected to low temperatures during the logistical chain of it or it was in an inverted position for a long period of time.Summary of follow up/corrective actions taken: no follow up actions were taken.For 1 of the events: summary of investigation results: no interfering factors were identified.A general product problem can be excluded.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.The investigation did not identify a product problem.Summary of follow up/corrective actions taken: the samples were received for investigation.

• Brand Name: ELECSYS T4
• Common Device Name: RADIOIMMUNOASSAY, TOTAL 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: 20516091
• Report Number: 1823260-2024-03052
• Device Sequence Number: 7045005
• Product Code: CDX
• UDI-Device Identifier: 07613336171677
• UDI-Public: 07613336171677
• Combination Product (Y/N): Y
• PMA/510(K) Number: K961490
• Exemption Number: VMSR
• Number of Events Summarized: 3
• 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): 01/22/2025

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 Model Number: T4
• Device Catalogue Number: 09007784190
• Device Lot Number: 79038201, 790382
• 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: 11/26/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 01/22/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown