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	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A falsely elevated concentrated carbon dioxide_2 (co2_c) result was obtained on a patient sample on a advia chemistry xpt instrument.The falsely elevated result was not reported to the physician(s).The sample was repeated on two alternate advia chemistry xpt instruments.The repeat results were lower than the erroneous result.A repeat results were reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated co2_c result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported a falsely elevated concentrated carbon dioxide_2 (co2_c) result was obtained on a patient sample on an advia chemistry xpt instrument.Quality controls (qc) recovered within acceptable ranges on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse found water in the reaction tray (rrv) bath.The water was removed from the rrv bath and dilution probes (dpp) 5, 6 and 7 were de-clogged from the reaction tray wash unit (wud).A cell blank and a precision study was performed with patient serum samples.The customer performed calibrations and quality control (qc), which recovered acceptably.The cause of the falsely elevated co2_c result is unknown.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; 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: 18185723
• Report Number: 2432235-2023-00303
• Device Sequence Number: 7238004
• Product Code: JJE
• UDI-Device Identifier: 00630414595467
• UDI-Public: 00630414595467
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/21/2023

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: 10/31/2023
• Initial Report FDA Received Date: 11/21/2023
• 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