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	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported falsely elevated carbon dioxide concentrated (co2_c) results for one patient sample that was obtained on the advia chemistry xpt analyzer with serial number (b)(6).The customer informed siemens that quality control (qc) was within range on (b)(6)2025 prior to processing patient samples.Siemens noted that a customer service engineer (cse) was not dispatched because the customer performed troubleshooting and maintenance cleaning on the reagent probes, and the customer has not observed a recurrence.Siemens is investigating the event.
Event or Problem Description
The customer reported falsely elevated carbon dioxide concentrated (co2_c) results for one patient sample that was obtained on the advia chemistry xpt analyzer with serial number (b)(6).The falsely elevated result (>40.0 mmol/l) was obtained four times and reported to the physician(s).The customer repeated the same sample on an alternate advia chemistry xpt analyzer, received a lower result that was considered correct, and issued an amended report.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated co2_c result.
Additional Manufacturer Narrative
The initial mdr was filed with the fda on 21-jan-2025.Additional information (25-feb-2025): siemens reviewed the analyzer data that was available, confirmed that quality control (qc) was within range on the day of the incident, and a siemens customer service engineer (cse) visited the site and performed services which included cleaning the reagent probes (rpp1 and rpp2), verified the performance of the advia chemistry xpt analyzer, and the customer noted no recurrence of the issue.The potential cause of the falsely elevated carbon dioxide concentrated (co2_c) results is the reagent probes and the issue was resolved by routine troubleshooting and maintenance.The analyzer is operational, and no further evaluation 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: rolando hualpa ; 511 benedict ave.; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 21199284
• Report Number: 2432235-2025-00025
• Device Sequence Number: 8341743
• 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): 02/27/2025

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: 01/13/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/27/2025
• 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