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

Catalog Number	10711433
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported running high-sensitivity troponin i (tnih) in triplicate, observing a tnih falsely elevated result on the advia centaur xpt analyzer, and not reporting the result to the physician(s).The customer used an alternate advia centaur xpt analyzer to perform repeat testing, ran the same sample in triplicate, and noted that the repeat results were consistent and considered correct.The customer informed siemens that there were no abnormalities with quality control (qc).Siemens dispatched a cse (customer service engineer) to the customer site and recommended services, including a precision run with neg qc or negative patient pool and running background tests (wetwater, wetwash1, and dry).The cse completed services, which included uv cleaning, performing maintenance and tests on the luminometer, verifying the dispense and aspiration of liquid, providing background tests, and precision run data for investigation.Siemens identified outliers with the dry, wetwater, and during the precision run, and recommended decontaminating the analyzer acid/base.The cse performed the additional services and verified the analyzer was operating as specified.Siemens is investigating the event.
Event or Problem Description
The customer reported running high-sensitivity troponin i (tnih) in triplicate, observing a tnih falsely elevated result on the advia centaur xpt analyzer, and not reporting the result to the physician(s).The customer used an alternate advia centaur xpt analyzer to perform repeat testing, ran the same sample in triplicate, and noted that the repeat results were consistent and considered correct.There is no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
Initial mdr 2432235-2025-00100 was filed on 31-mar-2025.Additional information (15-apr-2025): siemens reviewed the services performed and concluded that testing performed post-services, with pooled serum and qc (quality control), showed acceptable reproducibility.Return of the sample or further investigation is not warranted because the discordant result was not reproducible.The cause of the falsely elevated high-sensitivity troponin i (tnih) result on one patient sample is unknown.The advia centaur xpt analyzer is operating as specified, and no further evaluation is required.Siemens updated sections h4 to include the device manufacture date and h6 to include new codes that reflect the investigation conclusion.

• Brand Name: ADVIA CENTAUR XPT
• Common Device Name: ADVIA CENTAUR XPT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMIT; chapel lane; registration number: 8020888; swords, co., dublin ; EI
• Manufacturer Contact: rolando hualpa ; 511 benedict ave.; tarrytown, NY 10591 ; 9143485874
• MDR Report Key: 21750840
• Report Number: 2432235-2025-00100
• Device Sequence Number: 18197904
• 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,Followup
• Report Date (Section B): 04/23/2025

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 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: 03/25/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 04/23/2025
• 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: Unknown