MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY XPT SYSTEM

Model Number	10723034
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted siemens to report that two patient samples gave falsely elevated calcium (ca_2c) test results from an advia chemistry xpt system.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the system.The cse completed the following: all probe alignments performed, all mixer alignments performed, aspiration checks performed on wash station units (wud and dwud), 14mm seals replaced on the reagent wash pumps (rwp1 and rwp2).The cse ran a precision check on the calcium assay with acceptable results.Internal quality controls were run with acceptable results.The cause of the falsely elevated calcium test results is unknown.Mechanical alignments and worn 14mm seals on the reagent wash pumps are contributing factors to this event.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.
Event or Problem Description
The customer reported that two patient samples gave falsely elevated calcium (ca_2c) test results from an advia chemistry xpt system.The falsely elevated patient results were not reported to the physician(s).The same samples were repeated on an alternate advia chemistry xpt system.The repeat results were lower, considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated ca_2c results.

• Brand Name: ADVIA CHEMISTRY XPT SYSTEM
• Common Device Name: ADVIA CHEMISTRY XPT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; 3-1-2 musashino akishima; tokyo 196-8 558-; JA 196-8558-0
• Manufacturer Contact: karl aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 21347427
• Report Number: 2432235-2025-00046
• Device Sequence Number: 8959261
• Product Code: JJE
• UDI-Device Identifier: 00630414553160
• UDI-Public: (01)00630414553160
• 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): 02/10/2025

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: 01/23/2025
• Initial Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown