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	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that falsely elevated high-sensitivity troponin i (tnih) results were obtained on two patient samples on an advia centaur cp analyzer.The initial results were reported to the physician(s).For the first patient, two new samples were drawn at different times and processed on the original analyzer, which recovered lower than the initial result.Both the second and third drawn sample results were considered correct.Then, the customer repeated the original sample on the original analyzer and obtained a similar lower result, which was considered correct.The result of 21.0 pg/ml was reported as the correct result to the physician(s).For the second patient, the sample was repeated on an alternate advia centaur xp analyzer.The repeat result recovered lower than the initial result and was considered correct.The repeat result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated tnih results.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that falsely elevated high-sensitivity troponin i (tnih) results were obtained on two patient samples on an advia centaur cp analyzer.Quality control (qc) was within the acceptable range on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse performed the total service call, found a luminometer with dried liquid inside.The cse cleaned the luminometer, verified the dark count, replaced the aspirate wash pump tubing and aspirate line, verified the sample and reagent probes calibrations, decontaminated the rinse and wash 1 lines, and ran qc 10 times and patient samples, which recovered within acceptable limits.Siemens further evaluated the event and concluded that the wash block area of the system potentially contributed to the falsely elevated tnih results as unbound lite reagent not being fully washed from the cuvette.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR CP ANALYZER
• Common Device Name: ADVIA CENTAUR CP ANALYZER
• 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 ; WZ
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22076784
• Report Number: 2432235-2025-00136
• Device Sequence Number: 9363523
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: (01)00630414523286
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 05/23/2025

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 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: 05/06/2025
• Initial Report FDA Received Date: 05/23/2025
• 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