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	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely elevated total human chorionic gonadotropin (thcg) result was obtained on a patient sample on an advia centaur xpt analyzer.The erroneous result was reported to the physician(s), who questioned the result.The sample was repeated on an original analyzer.The repeat result recovered lower than the initial result and was considered correct.The repeat result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated thcg result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that a falsely elevated total human chorionic gonadotropin (thcg) result was obtained on a patient sample on an advia centaur xpt analyzer.Calibration and quality control (qc) were recovered within the range on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse ran dry/wet water/wet wash, which recovered within specifications; found leak at fluidic manifold on connections for wash 1 at dilution probe 1 (dp1) and dilution probe 2 (dp2), replaced fittings and checked for leaks, checked the performance of all dispense posts and aspirate probes, checked and adjusted vacuum flow and pressure, replaced check valves going into the wash manifold, reran sample 6 times and qc.The cause of the falsely elevated thcg result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2025-00204 on 07-aug-2025.Additional information (14-aug-2025): siemens further evaluated the event and has determined that there were no issues with the reagent as quality control (qc) recovered within acceptable ranges, and no issues were reported with other patient samples.Based on the siemens evaluation, it is concluded that the leak identified at the wash manifold potentially contributed to the falsely elevated thcg result.Qc and patient sample replicates were run post-service, produced expected results.The investigation conclusions code in the h6 section was updated to reflect the additional information.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: 22735646
• Report Number: 2432235-2025-00204
• Device Sequence Number: 13037516
• Product Code: JJE
• UDI-Device Identifier: 00630414596914
• UDI-Public: (01)00630414596914
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/21/2025

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: 07/23/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 08/21/2025
• 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 Age: 34 YR
• Patient Sex: Female