MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XPT ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the observation of a falsely elevated troponin (tnih) test result was obtained from an advia centaur xpt analyzer.The initial test result was not released to a physician.The same sample was repeated on an alternate advia centaur xpt analyzer.A lower test result was obtained and released to a physician as the correct result.The patient was receiving an immunotherapy treatment at time of the sample collection.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted siemens to report that a falsely elevated troponin (tnih) test result was obtained from an advia centaur xpt analyzer.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the analyzer.The cse found that tnih would not calibrate and that the performance of the low level quality control material (qc) was poor.The cse performed the total service call and found the vacuum pressure was acceptable, dark counts were acceptable, there was no bleach in the check valve and cleaned the de-ionizer.The cse found a cracked fitting on the wash displacement diluter.The cse replaced the fitting and repeated tnih calibration with acceptable results.The customer ran qc with acceptable results.The cause of the falsely elevated tnih was the cracked fitting.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.

• Brand Name: ADVIA CENTAUR XPT ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• 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.; dublin ; EI
• Manufacturer Contact: karl aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 24406301
• Report Number: 2432235-2026-00060
• Device Sequence Number: 9859244
• Product Code: JJE
• UDI-Device Identifier: 00630414596914
• UDI-Public: (01)00630414596914
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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: N/A
• Device Catalogue Number: 10711433
• Device Lot Number: N/A
• 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: 02/10/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown