MAUDE Adverse Event Report: SIEMENS HEALTHCAREDIAGNOSTICSINC. ADVIA CENTAUR XPT

Model Number	ADVIA CENTAUR XPT
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that false positive results for infectious disease assays were obtained on the advia centaur xpt analyzer with serial number: (b)(6) and reported to the physician(s).The customer stated that repeat testing was performed on an alternate analyzer, the repeat results were negative, considered correct, and that corrected reports were issued.Siemens dispatched a cse (customer service engineer) to the customer site.The cse performed troubleshooting and identified the water reservoir sensor was not detecting fluid.The cse performed services, which included replacing the fittings for the wash pumps and the pump for dispensing port 2, cutting back and reseated the wash manifold tubing, performing background tests, decontaminating the instrument, and other services without resolution.Siemens confirmed that no additional services were required because the analyzer was deinstalled by siemens.The cause of the false positive results for infectious disease assays is unknown.
Event or Problem Description
The customer reported that false positive results for infectious disease assays were obtained on the advia centaur xpt analyzer with serial number: (b)(6) and reported to the physician(s).The customer stated that repeat testing was performed on an alternate analyzer, the repeat results were negative, considered correct, and that corrected reports were issued.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Initial mdr 2432235-2025-00118 was filed on 21-apr-2025.Additional information (22-apr-2025): siemens reviewed the services performed by the cse (customer service engineer), which included checking the dispense volumes for acid/base, water, wash1 fluids, and the analyzer's alignments.The cse identified and cleaned debris from the reagent probe (r3) and replaced the sample and r2 probes and aspiration probe collars located in the wash station.The cse performed a follow-up visit and additional services, which included replacing the dispense port 2 diluter pump, performing background tests, and found the values were out of specification.Based on the background test results (wet/dry test) the cse performed a decontamination on the advia centaur xpt analyzer; however, siemens confirmed that no further troubleshooting was possible.The analyzer was deinstalled and removed from the customer site, and atellica solutions was considered a replacement.Since the assays are sensitive to contamination, siemens concluded that contamination is the potential cause of false positive results for infectious disease assays on the advia centaur xpt analyzer.The advia centaur xpt analyzer was deinstalled, and no further evaluation is required.

• Brand Name: ADVIA CENTAUR XPT
• Common Device Name: ADVIA CENTAUR XPT
• Manufacturer (Section D): SIEMENS HEALTHCAREDIAGNOSTICSINC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane; registration number: 8020888; swords, co., dublin ; EI
• Manufacturer Contact: rolando hualpa ; 511 benedict ave.; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 21876229
• Report Number: 2432235-2025-00118
• Device Sequence Number: 7803340
• Product Code: JJE
• UDI-Device Identifier: 00630414596914
• UDI-Public: (01)00630414596914
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 04/29/2025

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
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/29/2025
• 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: Unknown