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

Model Number	ADVIA CHEMISTRY XPT SYSTEM
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	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that an advia chemistry xpt system outputted an out-of-range quality control (qc) and erroneous results on multiple patient samples with multiple assays due to oil contamination.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse inspected the system, cleaned up the oil contamination, observed lamp/spectro was not functional, loaded approved bath oil on the system, and ran qc, which recovered acceptably.The customer stopped using the system.Siemens is evaluating the event.
Event or Problem Description
The customer reported that erroneous results were obtained on multiple patient samples with multiple assays on an advia chemistry xpt system.Among all the initial results, few results were not reported to the physician(s) as they were not realistic.The samples were repeated on an alternate advia chemistry xpt system.The repeat results were considered correct and reported to the physician(s).The customer did not provide the patient results data to siemens.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2025-00091 on 19-mar-2025.Additional information (26-mar-2025): siemens received the feedback from the customer that the instrument is no longer in use, and they moved to the alternate instrument for patient sample testing.

• Brand Name: ADVIA CHEMISTRY XPT SYSTEM
• Common Device Name: ADVIA CHEMISTRY XPT SYSTEM
• 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka ; 870577433
• MDR Report Key: 21640622
• Report Number: 2432235-2025-00091
• Device Sequence Number: 8425506
• Product Code: JJE
• UDI-Device Identifier: 00630414595467
• UDI-Public: (01)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,Followup
• Report Date (Section B): 04/04/2025

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 SYSTEM
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/04/2025
• 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