MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XPT ANALYZER

Model Number	ADVIA CENTAUR XPT ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center to report falsely elevated high-sensitivity troponin i (tnih) results were obtained on eight patient samples on an advia centaur xpt analyzer.Quality controls (qcs) recovered within ranges on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse replaced valve 39 and the aspirate probe 2.On subsequent visits, the cse replaced the reagent probe, acid pump and valve, base pump and valve, all pinch valves and tubing and resuspended the magnet.The separation manifold was serviced.The cse performed an instrument decontamination with hydrogen peroxide and cleaning solution.Tnih precision testing was performed, and all results were within acceptable ranges.Qc was performed and was within acceptable ranges.Siemens further evaluated the event and concluded that instrument related issues potentially contributed to the event.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported falsely elevated high-sensitivity troponin i (tnih) results were obtained on eight patient samples on an advia centaur xpt analyzer.The samples were repeated on the same instrument and an alternate advia centaur analyzer.The repeat results were lower than the erroneous results.The repeat results obtained on the alternate advia centaur analyzer for 7 patient samples were reported, as the correct results, to the physician(s).The repeat result from the initial instrument obtained for patient identified with sample id: (b)(6) was reported as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated tnih results.

• Brand Name: ADVIA CENTAUR XPT ANALYZER
• Common Device Name: ADVIA CENTAUR XPT ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 21452915
• Report Number: 2432235-2025-00068
• Device Sequence Number: 18063980
• Product Code: JJE
• UDI-Device Identifier: 00630414596914
• UDI-Public: (01)00630414596914
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2025

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 Model Number: ADVIA CENTAUR XPT ANALYZER
• Device Catalogue Number: 10711433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown