MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR; 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	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the customer care center (ccc) and reported that erroneously elevated progesterone (prge) results were obtained on multiple patient samples when processed on an advia centaur xp analyzer.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the analyzer, checked the error log and identified a volume check error (probe 1 volume check failure) on reagent needle 1.The cause of the event is unknown.The instrument is performing according to specifications.Siemens is evaluating the event.
Event or Problem Description
The customer reported that erroneously elevated progesterone (prge) results were obtained on multiple patient samples when processed on an advia centaur xp analyzer (s/n: (b)(6)).The initial results were reported to the physician(s) but were not questioned.The same samples were reprocessed on an alternate advia centaur xp analyzer and obtained lower results.The repeat results were considered correct.There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment due to the reported issue.
Additional Manufacturer Narrative
Mdr 2432235-2025-00194 was initially filed on 22-jul-2025.Additional information (30-jul-2025): siemens has concluded the investigation for the customer complaint of observation of erroneously elevated progesterone (prge) results were obtained on multiple patient samples when processed on an advia centaur xp analyzer.In addition to the service activities mentioned in the initial report, the siemens customer service engineer (cse) observed that the probe shutter was not opening properly during the movement of the reagent probes and the plate adapter for the probe shutter was worn.The cse replaced the plate adapter, reagent cam shutter, reagent probe 1 along with its sleeve and performed alignments on all three reagent probes.Following the service intervention, the cse ran a quality control (qc) which recovered acceptably.Siemens further evaluated the event and determined that the probable cause of the issue was due to the defective plate adapter of probe shutter.The instrument is performing according to specification and the reported issue was resolved by routine troubleshooting.No further evaluation of this device is required.In section h6 of this report, the component code and investigation conclusions codes were updated based on the investigation results.

• Brand Name: ADVIA CENTAUR
• Common Device Name: ADVIA CENTAUR XP ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; 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: 22566842
• Report Number: 2432235-2025-00194
• Device Sequence Number: 9348147
• 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,Followup
• Report Date (Section B): 08/25/2025

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: 06/27/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/25/2025
• 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