MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CP IMMUNOASSAY SYSTEM

Model Number	ADVIA CENTAUR CP IMMUNOASSAY SYSTEM
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a falsely elevated high-sensitivity troponin i (tnih) result was obtained on a patient sample on a advia centaur cp.The patient had 3 tnih samples collected.After the result from sample 3 correlated with sample 1, the customer reran sample 2 since it was inconsistent with the other results.The customer recentrifuged sample 2 and obtained a lower test result.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated tnih result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report a falsely elevated high-sensitivity troponin i (tnih) result that was obtained on a patient sample on an advia centaur cp immunoassay system.Quality control (qc) and calibration recovered within ranges at the time of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.The cse found that the luminometer waste probe was partially occluded, causing build up in the luminometer.The cse styleted the probe, removed the luminometer rotor, and cleaned the rotor and luminometer housing.The cse then verified the system fluidics, the sample probe and reagent probe alignments.The customer ran qc which was found to be within ranges.Siemens further evaluated the event and concluded that the actions taken by the cse were normal troubleshooting activities and the potential cause could not be determined.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR CP IMMUNOASSAY SYSTEM
• Common Device Name: ADVIA CENTAUR CP IMMUNOASSAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; neuwiesenstrasse 4; registration #: 3008494306; beringen 8222 ; SZ 8222
• Manufacturer Contact: sumaiya ; 511 benedict ave.; tarrytown, NY 10591 ; 5513306538
• MDR Report Key: 23657365
• Report Number: 2432235-2025-00299
• Device Sequence Number: 20059378
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: (01)00630414523286
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K041133
• 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): 11/26/2025

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 CP IMMUNOASSAY SYSTEM
• Device Catalogue Number: 10309710
• 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: 11/05/2025
• Initial Report FDA Received Date: 11/26/2025
• 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