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

Model Number	ADVIA CENTAUR XPT ANALYZER
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	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported elevated high-sensitivity troponin i (tnih) results were obtained on a primary patient sample and on an aliquot of the same patient sample on an advia centaur xpt analyzer.These samples were processed at the same time and the results (63.10 ng/l and 184.39 ng/l, respectively) were not reported to the physician(s).The primary sample and aliquot were repeated multiple times on the same advia centaur xpt analyzer.The repeat results were lower than the initial results.The customer did not report the results and requested a new sample draw from the patient.The correct result for this patient is unknown.There are no known reports of patient intervention or adverse health consequences due to the elevated tnih results.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center to report elevated high-sensitivity troponin i (tnih) results were obtained on a primary patient sample and on an aliquot of the same patient sample on an advia centaur xpt analyzer.Quality controls (qcs) and calibration recovered out of ranges on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse found leaking fittings and dilutor.The cse replaced the fittings.On a subsequent visit, the cse replaced the leaking dilutor, checked the fittings and dilutor tightness, flushed the liquids and ran calibrations and qcs, which recovered within ranges.Siemens further evaluated the event and concluded that the leaking 5ml dilutor and 2 fittings potentially contributed to the event.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR XPT ANALYZER
• Common Device Name: ADVIA CENTAUR XPT ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 21255210
• Report Number: 2432235-2025-00033
• Device Sequence Number: 8055717
• Product Code: JJE
• UDI-Device Identifier: 00630414596914
• UDI-Public: (01)00630414596914
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141999
• 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): 01/28/2025

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 CENTAUR XPT ANALYZER
• Device Catalogue Number: 10711433
• 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: 01/20/2025
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2021
• 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: Male