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	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that falsely elevated total human chorionic gonadotropin (thcg) results were obtained on three (3) patient samples when processed on an advia centaur xpt analyzer.The calibration and quality control (qc) were in range on the day of the event.Siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the instrument, performed a decontamination of the system and found that the acid pump malfunctioned.Then, the cse replaced and primed the acid pump, installed new reservoirs and primed the system.Next, the cse ran qc and a patient sample, which recovered acceptably.The cause of the event is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that falsely elevated total human chorionic gonadotropin (thcg) results were obtained on three (3) 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 and obtained lower results.The lower results were considered correct since it matched the clinical history of the patients and were reported to the physician(s).There is no known reports of patient intervention or adverse health consequences due to the elevated thcg results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2025-00062 on 20-feb-2025.Additional information (06-mar-2025): in addition to the service activities mentioned in the initial report, a siemens customer service engineer (cse) replaced the wash separation manifold, 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 falsely elevated total human chorionic gonadotropin (thcg) results.Component code and investigation conclusions codes in section h6 were updated to reflect the additional information.The instrument 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: 21419151
• Report Number: 2432235-2025-00062
• Device Sequence Number: 21164191
• 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,Followup
• Report Date (Section B): 03/27/2025

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: 01/27/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 03/27/2025
• 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