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

Model Number	10723034
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted siemens to report that a falsely depressed sodium test result was obtained from an advia chemistry xpt.The customer reported that a clot error was generated by the system.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the analyzer.The cse replaced the ise buffer valve, replaced the ise buffer and primed the ise module.Ise calibration and quality control materials were run with acceptable results.The cause of the falsely depressed sodium test result is unknown.The ise buffer valve is a potentially contributing factor to the event.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.
Event or Problem Description
The customer contacted siemens to report that one falsely depressed sodium test result was obtained from an advia chemistry xpt.The initial test result was not released to the physician(s).The same sample was repeated on an alternate advia chemistry xpt and a higher test result was obtained.The repeat test result was released to the physician(s) as the correct test result.There are no known reports of patient intervention or adverse health consequences due to the event.

• Brand Name: ADVIA CHEMISTRY XPT
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; 3-1-2 musashino akishima; tokyo ; JA
• Manufacturer Contact: karl aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 22520792
• Report Number: 2432235-2025-00187
• Device Sequence Number: 8012135
• Product Code: JJE
• UDI-Device Identifier: 00630414595467
• UDI-Public: 00630414595467
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/16/2025

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: 10723034
• Device Catalogue Number: 10723034
• 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: 07/12/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown