MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP ANALYZER

Model Number	ADVIA CENTAUR XP ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) and reported that erroneously elevated carcinoembryonic antigen (cea) & alpha-fetoprotein (afp) results on multiple patient samples on an advia centaur xp analyzer.Quality control (qc) was within range prior to running patient samples.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse observed that all reagent probes were slightly bent, misaligned and the probe shutter was not opening properly during the movement of the reagent probes.Upon further investigation, the cse identified that the plate adapter for the probe shutter was worn.The cse replaced the plate adapter, reagent cam shutter, reagent probe 1 (r1) and its sleeve, performed alignment for all three reagent probes, ran qc which recovered within acceptable ranges.Siemens further evaluated the event and concluded that the defective plate adapter of the probe shutter due to normal wear and tear, potentially contributed to the reported event.The analyzer is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that erroneously elevated alpha fetoprotein (afp) and carcinoembryonic antigen (cea) results were obtained on multiple patient samples when processed on an advia centaur xp analyzer.The initial results were reported to the physician(s) and were not questioned.The samples were repeated on the original analyzer.The repeat results obtained were consistent with the patient's history and considered correct.The repeat results were reported as correct results to the physician.There are no known reports of patient intervention or adverse health consequences due to the elevated afp and cea results.

• Brand Name: ADVIA CENTAUR XP ANALYZER
• Common Device Name: ADVIA CENTAUR XP 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: 22402253
• Report Number: 2432235-2025-00177
• Device Sequence Number: 8408058
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: (01)00630414573564
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K041133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/04/2025

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 XP ANALYZER
• Device Catalogue Number: 10364455
• 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: 06/11/2025
• Initial Report FDA Received Date: 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2015
• 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