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	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that a falsely elevated total human chorionic gonadotropin (thcg) result was obtained on a patient sample on an advia centaur xpt analyzer.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 inspected the instrument and found a fluid wash leak with a quick connect, replaced the fitting and primed the system.The customer then recalibrated and ran quality controls (qc) which was acceptable.The cse then performed a precision test using the positive and negative controls in replicates of 4 each and all results were acceptable.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 an erroneously elevated total human chorionic gonadotropin (thcg) result was obtained on a patient sample on an advia centaur xpt analyzer.The initial result was reported to the physician(s), who questioned the result.The sample was repeated on an alternate advia centaur cp analyzer.The repeat result recovered lower than the initial result and was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated thcg result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2025-00130 on 09-may-2025.Additional information (11-may-2025): additional patient sample details updated in section b6.In addition to the service activities mentioned in the initial report, the siemens customer service engineer (cse) identified a cracked wash 1 fitting in the fluidics drawer.The cse then replaced all fluids and primed lines, removed and cleaned aspirate probe wash guides, verified acid/base dispenses, performed dark count readings, cleaned the ionizer, and confirmed that there was no bleach present.The customer ran quality control (qc) and patient sample which recovered within the established ranges.The customer then ran a comparison study with their advia centaur cp analyzer, and all the results are in line with the original results.Siemens further evaluated the event and determined that the hardware issues addressed by service and/or pre-analytics potentially contributed to the falsely elevated total human chorionic gonadotropin (thcg) result.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 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: 21996210
• Report Number: 2432235-2025-00130
• Device Sequence Number: 17215348
• 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,Followup
• Report Date (Section B): 06/03/2025

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: 04/17/2025
• Supplement Date Received by Manufacturer: 05/11/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/03/2025
• 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: Female