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	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that false positive total human chorionic gonadotropin (thcg) results were obtained on six patient samples on an advia centaur xpt analyzer.The erroneous results were reported to the physician(s), who questioned the results.The samples were repeated on the original analyzer with new reagent pack.The repeat results recovered negative.The repeat results were considered correct and reported to the physician(s) as they were consistent with the patient¿s clinical history.There are no known reports of delay, patient intervention, or adverse health consequences due to the false positive thcg results.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that total human chorionic gonadotropin (thcg) results were obtained on six patient samples on an advia centaur xpt analyzer.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the analyzer, reviewed the error logs, performed the total service protocol, checked the dark count values, inspected the analyzer for leaks, verified the aspiration and dispense functions for all probes, and calibrated the reagent probe 1.During the next visit, the cse identified a small leak in the wash displacement (wd) water probe area, replaced the wash manifold and the wash separation manifold.After this, the cse ran precision and quality control (qc), which recovered within acceptable ranges.Siemens evaluated the event and concluded that the cause of the event is inconclusive.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: 22226194
• Report Number: 2432235-2025-00152
• Device Sequence Number: 18269045
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2025

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: 05/22/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown