MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-TSHR; THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM

Catalog Number	08496609190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The field service engineer (fse) checked fluidics, cleaned the sample and reagent probes, verified the liquid level detection voltage, checked the mixer, calibrated the sipper needle, replaced the measuring cell, performed measuring cell preparation and system volume check, ran blank cell calibration, and performed calibration and qc successfully.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys anti-tshr results for multiple patient samples on a cobas e411 module.The customer provided examples of results for 4 patient samples.The customer questioned the results as they did not match the clinical pictures of the patients.For sample 1, the result was 1.7 iu/l.For sample 2, the result was 1.8 iu/l.For sample 3, the result was 1.6 iu/l.For sample 4, the result was 5 iu/l.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
Section d4, product lot number has been updated.The service maintenance actions performed by the fse resolved the issue.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: ELECSYS ANTI-TSHR
• Common Device Name: THYROID AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
• 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 46250-0457
• MDR Report Key: 23416580
• Report Number: 1823260-2025-04408
• Device Sequence Number: 16060148
• Product Code: JZO
• UDI-Device Identifier: 07613336160305
• UDI-Public: 07613336160305
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K193313
• 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
• Report Date (Section B): 12/05/2025

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 Catalogue Number: 08496609190
• Device Lot Number: 840177
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/05/2025
• 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