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

Model Number	ADVIA CENTAUR XPT ANALYZER
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that erroneous total human chorionic gonadotropin (thcg) results were obtained on multiple patient samples when processed on an advia centaur xpt analyzer.The initial results were not reported to the physician(s).The same samples were reprocessed on the original analyzer.The repeat results were considered and were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneous thcg results.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that erroneous total human chorionic gonadotropin hcg (thcg) results were obtained on multiple patient samples when processed on an advia centaur xpt analyzer.Quality control (qc) and calibration were within the laboratory established ranges.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse decontaminated the analyzer, replaced the wash separation manifold, acid and base pumps, reagent probes 1 (r1) and 2 (r2), luminometer, vacuum regulator, and waste reservoir bottle tubing/cap.Siemens further evaluated the event and concluded that the issue with the vacuum caused the erroneous thcg results.The analyzer is performing according to specifications.No further evaluation of this device is required.

• 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 21557761
• Report Number: 2432235-2025-00084
• Device Sequence Number: 21147611
• Product Code: JJE
• UDI-Device Identifier: 00630414596914
• UDI-Public: (01)00630414596914
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 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 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: 02/13/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2017
• 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