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
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 e801 analytical unit and for 1 patient tested for elecsys t4 on a cobas 8000 e 602 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
For 1 of the events: summary of investigation results: the investigation did not a product problem.The cause of the event was consistent with a pre-analytical issue (a clot was detected in the sample) at the customer's site.Pre-analytical is within the customer's responsibility.Summary of follow up/corrective actions taken: the analyzer was checked and no problem was found.For 1 of the events: summary of investigation results: a general reagent issue can be excluded, as a different reagent kit from the same lot performed according to expectations at the customer site.The customer did not perform qc on the reagent before use.Per product labeling: "controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per cobas e pack, and following each calibration." the specific cause of the event could not be determined; however, the event is consistent with a storage or transportation issue.Summary of follow up/corrective actions taken: the customer replaced the reagent pack and the issue was resolved.

• 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: 21273320
• Report Number: 1823260-2025-00282
• Device Sequence Number: 3942836
• Product Code: CDX
• UDI-Device Identifier: 07613336171677
• UDI-Public: 07613336171677
• Combination Product (Y/N): N
• PMA/510(K) Number: K961490
• 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,Followup
• Report Date (Section B): 02/13/2025

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: 79038201,74460301
• 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: 01/27/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 02/13/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown