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	01/03/2025
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 the advia centaur xpt analyzer.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the instrument, performed total service visit, replaced the sample syringe assembly, and pinch valve tubing and verified the operation of the instrument.The customer ran samples.Then, the cse replaced aspirate probes 1, 2, 3, and 4, probe assembly, tubing, wash arounds, pinch valve assemblies, and syringe diluters.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 a falsely elevated total human chorionic gonadotropin (thcg) result was obtained on a patient sample on the advia centaur xpt analyzer.The initial result was reported to the physician(s).The patient was redrawn, and the redrawn sample was processed on the original analyzer.On the subsequent day, the original sample was reprocessed on the original analyzer.The repeat results obtained from both samples were <1 miu/ml.The repeat results were reported as correct results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to a falsely elevated thcg result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2025-00036 on 30-jan-2025.Additional information (06-mar-2025): in addition to the service activities mentioned in the initial report, the siemens customer service engineer (cse) decontaminated the system and replaced the wash separation manifold, acid and base pumps, reagent probes 1 and 2, 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 thcg result.Component 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 avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 21271925
• Report Number: 2432235-2025-00036
• Device Sequence Number: 8090472
• 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): 03/21/2025

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: 01/06/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/21/2025
• 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