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	02/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A falsely elevated concentrated carbon dioxide (co2_c) result was obtained on a patient sample on an advia chemistry xpt instrument.The erroneous result was not reported to the physician(s).The sample was repeated for co2_c on the same analyzer, recovering lower.The lower result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc).Quality controls recovered within acceptable ranges at the time of the event.A siemens customer service engineer (cse) was dispatched to the customer site.The cse replaced the cdp (dilution wash pump) tubing, rebuilt the vacuum pump, and cleared the wud (reaction tray washer) pipe.In a subsequent visit, the cse rebuilt vacuum pump and also replaced the cdev (reaction tray wash unit drain valve).Quality controls (qc) recovered acceptably after service intervention.The cause of the event is consistent with instrument related factors.The analyzer 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; registration #: 3003637681; 3-1-2 musashino akishima; tokyo, 196-8 558; JA 196-8558
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 16531150
• Report Number: 2517506-2023-00091
• Device Sequence Number: 5979875
• Product Code: JJE
• UDI-Device Identifier: 00630414595467
• UDI-Public: 00630414595467
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/13/2023

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): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 03/13/2023
• 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