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)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).The competitor method is snibe.The sample was requested for investigation.
Event or Problem Description
The initial reporter questioned thyroid results for 1 patient on a cobas e 801 analytical unit compared to a competitor method.Of the data provided, the results for ft3, t4, t3, anti-tg and anti-tpo were discrepant.Refer to the attached data for the patient results.This medwatch will cover t4.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft3 results, medwatch with a1 patient identifier (b)(6) for information on the t3 results, medwatch with a1 patient identifier (b)(6) for information on the anti-tg results and medwatch with a1 patient identifier (b)(6) for information on the anti-tpo results.
Additional Manufacturer Narrative
Medwatch fields d4 lot number, expiration date and catalog number, udi number, and g4 pma / 510k were updated.
Additional Manufacturer Narrative
The sample was submitted for investigation.Upon further investigation of the patient sample, an interferent against the streptavidin component of the reagent was confirmed.This interference is covered in product labeling: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.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.

• 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 46250-0457
• MDR Report Key: 21306967
• Report Number: 1823260-2025-00333
• Device Sequence Number: 12973803
• Product Code: CDX
• UDI-Device Identifier: 07613336171677
• UDI-Public: 07613336171677
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: T4
• Device Catalogue Number: 09007784190
• Device Lot Number: 790382
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 02/04/2025; 03/04/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 02/19/2025; 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown