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

Model Number	ADVIA CHEMISTRY XPT
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted siemens to report that one discordant calcium_2 concentrated (ca_2c) test result was obtained on each of twelve samples from an advia chemistry xpt instrument.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the instrument.The cse replaced two concentrated drain pump (cdp) tubing cassettes and repaired mechanical play in the reagent turn table 1 (rtt_1) by adjusting a bearing and bushings assembly.The cause of the discordant calcium_2 concentrated (ca_2c) test results is unknown.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.
Event or Problem Description
One discordant calcium_2 concentrated (ca_2c) test result was obtained on each of twelve samples from an advia chemistry xpt instrument.The initial results were reported to the physician(s).The same patient samples were repeated on an alternate advia chemistry xpt instrument and 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 event.

• 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: karl aebig ; 511 benedict ave; registration #: 2432235; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 16648906
• Report Number: 2517506-2023-00116
• Device Sequence Number: 5503810
• Product Code: JJE
• UDI-Device Identifier: 00630414595467
• UDI-Public: 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
• Report Date (Section B): 03/30/2023

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: 03/21/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2015
• 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