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

Model Number	ADVIA CENTAUR CP ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported an erroneously elevated high-sensitivity troponin i (tnih) result was obtained on a patient sample on an advia centaur cp analyzer.Calibration and quality control (qc) recovered within range on the event date(s).The customer recentrifuged samples and performed repeat testing on this same system and results were not precise.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse ran qc five times and observed no leaks, turned the system off and visually inspected cuvettes, replaced wash station block, aspirate probe tubing, gray peri pump tubing, and reagent probe, rerouted waste and water tubings.Then, the cse performed sample and reagent probe alignments, empty and fill ring and checked system fluidics, which recovered acceptably.Next, the cse filled water container with 2 gallons of nerl water, added 2 containers of wash 1, replaced acid and base with new ones, added 2 bags of cuvettes, and replaced tip trays.The cse visually inspected the system, which showed three small puddles on surface of clear acrylic incubation ring cover, discovered aspirate wash block 1 leaking.The cse swapped wash blocks, reseated all tubing¿s, resumed module, the reagent probe wash bowl overflowing and spilling onto clear acrylic cover, cleaned thoroughly and dried cover, replaced reagent probe waste pump, resumed module, and there were no overflows or errors.Further, the cse replaced the gray peristaltic pump, membrane pump, both aspiration wash blocks, and reagent probe syringe, verified all fluidics in gservice, performed empty and fill ring, ran patient precision study and observed reagent probe wash bowl overflowing.The cse stopped the system and tested reagent probe waste pump in gservice, resumed module and checked lines from wash bowl to waste reservoir, there were no kinks or clogs, resumed module and observed wash bowl close but did not overflow, ran qc and maintenance control module (mcm) along with low patient samples in replicates post service to verify system performance.The cause of the erroneously elevated tnih result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that an erroneously elevated high-sensitivity troponin i (tnih) result was obtained on a patient sample on an advia centaur cp immunoassay system.The erroneous result was reported to the physician(s), who did not question the result.The sample was repeated on original system and obtained imprecise results and were considered discordant.Two hours later, a new sample was drawn and tested on the original system and obtained erroneous result.The newly drawn sample was repeated on the original system and obtained imprecise results and were considered discordant.The customer mentioned that they had to move the patient samples to another platform for troponin testing, however they did not have any further results from that platform.Therefore, the correct results data to the siemens is unknown.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated tnih result.

• Brand Name: ADVIA CENTAUR CP ANALYZER
• Common Device Name: ADVIA CENTAUR CP ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; neuwiesenstrasse 4; registration #: 3008494306; beringen 8222 ; SZ 8222
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 23725194
• Report Number: 2432235-2025-00304
• Device Sequence Number: 10720914
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: (01)00630414523286
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/05/2025

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 ANALYZER
• 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: 11/12/2025
• Initial Report FDA Received Date: 12/05/2025
• 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: Male