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	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that an erroneously elevated high-sensitivity troponin i (tnih) and total human chorionic gonadotropin (thcg) results were obtained on multiple patient samples on an advia centaur xpt instrument.Quality control (qc) was acceptable on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse identified a small leak in the wash displacement (wd) water probe area.The cse replaced the wash manifold and subsequently the wash separation manifold, conducted precision tests for both the tnih and thcg assays, with results recovered within the acceptable ranges and re-ran qc samples, which were acceptable.The cse monitored the system's performance post-service and confirmed that no further discordant results were observed.Siemens further evaluated the event and the cause of the event is unknown.The reported event was resolved with routine troubleshooting actions.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that erroneously elevated high-sensitivity troponin i (tnih) and total human chorionic gonadotropin (thcg) results were obtained on multiple patient samples on the advia centaur xpt analyzer.The initial results were reported to the physician(s), who questioned the results.The samples were repeated on an alternate advia centaur cp analyzer.The repeat results recovered lower than the initial results, which were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.

• Brand Name: ADVIA CENTAUR XPT ANALYZER
• Common Device Name: ADVIA CENTAUR XPT ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22283476
• Report Number: 2432235-2025-00153
• Device Sequence Number: 8310023
• Product Code: JJE
• UDI-Device Identifier: 00630414596914
• UDI-Public: (01)00630414596914
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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: 05/23/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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