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

Model Number	ADVIA CHEMISTRY XPT
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted a siemens customer care center to report falsely elevated concentrated carbon dioxide (co2_c) results were obtained on 2 patient samples on an advia chemistry xpt instrument.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse removed the vacuum pump, inspected the diaphragms and cleaned beneath the leaf springs.A probe calibration was performed, and the mixer heights were checked and adjusted.The peristaltic pump tubing was replaced on drain pump 1 (cdp-1) and drain pump 2 (cdp-2).Aspiration checks were performed on the reaction tray wash unit (wud) and the dilution tray wash unit (dwud).The vacuum valve 1 (voev1) and the vacuum valve 2 (voev2) were stripped and cleaned.The vacuum tank and reaction tray (rrv) cuvette segments were removed, and the bath oil was cleaned.The cse cleaned the wash ports, performed a shutdown wash and a cell blank, and ran quality controls (qcs), which recovered within ranges.The cause of the erroneous results is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported falsely elevated concentrated carbon dioxide (co2_c) results were obtained on 2 patient samples on an advia chemistry xpt instrument.The erroneous results were not reported to the physician(s).The samples were repeated on an alternate advia chemistry xpt instrument.The repeat results were lower than the erroneous results.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated co2_c results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2025-00018 on 13-jan-2025.Additional information (29-jan-2025): in addition to the service actions described in the initial report, a siemens customer service engineer (cse) also replaced the 1mm l ring seals on the sampling pump, 7mm seals on the dilution probe discharge pump and the reagent pump 1 and cleaned the cuvettes.Siemens further evaluated the event and concluded that hardware issues potentially contributed to the falsely elevated concentrated carbon dioxide (co2_c) results.The component code and the investigation conclusions code in section h6 were updated to reflect the additional information.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CHEMISTRY XPT
• 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; registration #: 3003637681; tokyo 196-8 558; JA 196-8558
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 21143965
• Report Number: 2432235-2025-00018
• Device Sequence Number: 9088459
• Product Code: JJE
• UDI-Device Identifier: 00630414595467
• UDI-Public: (01)00630414595467
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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
• 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: 01/04/2025
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/20/2025
• 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