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	05/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) to report that erroneous results for multiple assays were generated for patient samples on an advia chemistry xpt instrument.A siemens customer service engineer (cse) went to the customer¿s site.During the visit, the cse determined that the instrument had dirty cuvette bath oil and probe arm issues.Then, the cse replaced cuvette oil, sample dilution probe, and reagent probe 1.Next, the cse processed quality controls (qcs) successfully and performed an acceptable sample comparison study between instruments.In a subsequent visit, the cse replaced the wash nozzles on the reaction tray wash unit (wud) and verified proper adjustment of the nozzles.The customer successfully processed qc.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
Erroneous results for multiple assays were generated for patient samples on an advia chemistry xpt instrument.The initial results were not reported to the physician(s) the samples were repeated on alternate advia chemistry xpt instruments.The repeat results were reported to the physician(s), as the correct results, as they agreed with the patients¿ medical history.This report is being filed in an abundance of caution as the customer did not quantify the number of samples impacted by this event and did not provide supporting patient data.There are no known reports of patient intervention or adverse health consequences due to the erroneous results.

• Brand Name: ADVIA CHEMISTRY XPT
• Common Device Name: ADVIA CHEMISTRY XPT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; 3-1-2 musashino akishima; registration #: 3003637681; tokyo 196-8 558; JA 196-8558
• Manufacturer Contact: douglas stanton ; 511 benedict ave.; tarrytown, NY 10591 ; 9142706592
• MDR Report Key: 17100642
• Report Number: 2432235-2023-00147
• Device Sequence Number: 1894804
• Product Code: JJE
• UDI-Device Identifier: 00630414595467
• UDI-Public: 00630414595467
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/09/2023

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: 05/15/2023
• Initial Report FDA Received Date: 06/09/2023
• 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