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	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of united states (ous) customer contacted a siemens customer care center (ccc) and reported that an elevated alpha-fetoprotein (afp) result was obtained on a patient sample on an advia centaur xp analyzer.Quality control was acceptable on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse, checked and found that the tubing was a little cracked and leaked at the connecting position to aspiration probe 1.The cse replaced the tubing.The cause of the event is unknown.Siemens is evaluating the event.
Event or Problem Description
The customer reported that an elevated alpha-fetoprotein (afp) result was obtained on a patient sample on an advia centaur xp analyzer.The initial result was not reported to the physician(s).The sample was repeated on an alternate advia centaur xp analyzer.The repeat result was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to falsely elevated afp result.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2025-00211 on 14-aug-2025.Additional information (26-aug-2025): in addition to the service activities mentioned in the initial report, the customer service engineer (cse) ran quality control (qc), which recovered acceptably.Siemens further evaluated the event and concluded that the improper aspiration by the aspiration probe 1 potentially contributed to the elevated alpha-fetoprotein (afp) result.The investigation findings and investigation conclusions code in section h6 were updated to reflect the additional information.The instrument is performing according to specifications.No product problem identified.

• 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; registration number: 8020888; chapel lane, swords, co.; dublin ; EI
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22806895
• Report Number: 2432235-2025-00211
• Device Sequence Number: 15403358
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: (01)00630414573564
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 09/09/2025

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: 08/05/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2018
• 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