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	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report falsely elevated high-sensitivity troponin i (tnih) results were obtained on 2 patient samples on advia centaur cp immunoassay system.Quality controls (qcs) recovered within range on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse replaced the rinse block.The cse performed a visual inspection, reviewed the error log, data and performed a total service visit.The cse found a dark count spike and cleaned the luminometer and photo multiplier tube (pmt), performed a precision study in 10 replicates and all results were within the expected range.Siemens further evaluated the event and the probable cause of the falsely elevated tnih results could not be determined based on replacement and servicing of multiple parts which is part of routine troubleshooting.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported falsely elevated high-sensitivity troponin i (tnih) results were obtained on 2 patient samples on advia centaur cp immunoassay system.The erroneous results were reported to the physician(s), who questioned the results.The patients were redrawn one hour later and tested on an alternate advia centaur xpt immunoassay system.The redrawn sample results were lower than the erroneous results.The redrawn sample results were reported, as the correct results, to the physician(s).The initial sample for patient with sample identifier (b)(6) was tested again on the initial advia centaur cp immunoassay system and obtained a lower result.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated tnih results.

• 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: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 23413871
• Report Number: 2432235-2025-00282
• Device Sequence Number: 21103398
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: (01)00630414523286
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/29/2025

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: 10/15/2025
• Initial Report FDA Received Date: 10/29/2025
• 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