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

Model Number	ADVIA CHEMISTRY XPT SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that falsely depressed concentrated calcium_2 (ca_2c) results were obtained on multiple patient samples on an advia chemistry xpt system.The initial results were not reported to the physician(s).The samples were repeated on an alternate instrument.The customer did not specify which instrument was used for the repeat testing.The repeat results were considered correct.The customer did not provide sample data to siemens.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed ca_2c results.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that falsely depressed concentrated calcium_2 (ca_2c) results were obtained on multiple patient samples on an advia chemistry xpt system.Quality control (qc) and calibrations were acceptable on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected the instrument, found the dilution tray was leaking and overflowing, and suspected that the leak dripped into adjacent cuvettes in dilution turntable tray (dtt).Then, the cse cleaned dilution reaction tray wash unit (dwud) dispense probes (nozzles) and performed wash maintenance.Further, the cse ran instrument with no further signs of fluid residue and ran qc, which recovered, acceptably.Siemens evaluated the event and concluded that dwud nozzles block issue potentially contributed to the falsely depressed ca_2c results the instrument is performing according to specifications.No further evaluation is required.

• Brand Name: ADVIA CHEMISTRY XPT SYSTEM
• Common Device Name: ADVIA CHEMISTRY XPT SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; 3-1-2 musashino akishima; registration #: 3003637681; tokyo 196-8 558; JA 196-8558
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 21592124
• Report Number: 2432235-2025-00086
• Device Sequence Number: 18373927
• Product Code: JJE
• UDI-Device Identifier: 00630414595467
• UDI-Public: (01)00630414595467
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K990346
• 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
• Report Date (Section B): 03/13/2025

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 CHEMISTRY XPT SYSTEM
• 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: 02/17/2025
• Initial Report FDA Received Date: 03/13/2025
• 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