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	10/31/2025
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 the advia centaur cp analyzer.Quality control (qc) recovered within range on the event date.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse performed total service visit (tsv), checked the wash station dispenses, aspirations and found that the aspirate probe 1 (a1) was not aspirating fully.The cse replaced the gray peri-pump tubing, checked reagent and sample probe aspirations and dispenses, ran dark counts without cuvettes, inspected and cleaned the interior of the luminometer, precipitate around the aspirate waste probe, swapped a1 and aspirate probe 2 (a2), reseated tubings on probes and waste peripump tubing, performed empty and fill ring in case fluid dripped in unused cuvettes.The cse then performed a precision study with patient samples and ran quality control (qc), which recovered acceptably.Siemens further evaluated the event and concluded that the instrument malfunction potentially contributed to the erroneously elevated high-sensitivity troponin i (tnih) result.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 the advia centaur cp immunoassay system.The patient was admitted to the emergency room (er).The customer confirmed that the patient was not admitted to the er specifically due to the erroneously elevated tnih result.The erroneous result was reported to the physician(s) but not questioned.The sample was repeated twice on the original analyzer and obtained lower results, which were considered correct, and a result of 4.02 was reported as correct result to the physician.A corrected report was issued.The patient was redrawn and repeated on the original advia centaur analyzer and obtained a lower result.There are no known reports of patient intervention or adverse health consequences, no impact on patient care, and no treatment provided or delayed 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: 23677665
• Report Number: 2432235-2025-00301
• Device Sequence Number: 16026844
• 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): 12/01/2025

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: 11/07/2025
• Initial Report FDA Received Date: 12/01/2025
• 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 Age: 69 YR
• Patient Sex: Female