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	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of a falsely elevated high-sensitivity troponin i (tnih) result was obtained on an emergency room (er) patient sample on an advia centaur cp analyzer.An emergency room (er) patient sample was initially tested, yielding a result of <3 pg/ml.The primary tube was then retested on a non-siemens instrument, which produced a lower result, this result was not reported to the physician(s).After two hours, a new sample was drawn from the er patient and processed on the original analyzer.The newly drawn sample result recovered higher than the initially drawn sample and was considered erroneous.The newly drawn sample result was reported to the physician(s) who did not question the result.The newly drawn sample was subsequently repeated in triplicate on the original analyzer.The repeat results recovered lower than the discordant result and were considered correct.The mean of repeat results was reported to the physician(s).The customer mentioned that there was no treatment provided or delayed based on the erroneous result and there was no delay in reporting results.There are no known reports of patient intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding observation of a falsely elevated high-sensitivity troponin i (tnih) result obtained on an emergency room (er) patient sample on an advia centaur cp analyzer.A siemens customer service engineer (cse) was dispatched to the customer¿s site, during the visit, the cse investigated wash bowl overflow and replaced tubing, both aspiration wash blocks and reagent probe waste pump twice, checked tubing from waste pump to waste reservoir, corrected a kink in the waste line beneath the tip tray drawer, restoring proper wash bowl aspiration, ran successful multi-diluent tests with no overflow.Further, the cse found waste tubing partially kinked reducing waste flow, performed acid/base line decontamination and daily maintenance, ran calibration, quality control (qc) which recovered acceptably.Next, the cse replaced sample probe syringe, sample diluter, sample syringe and sample probe diluter, performed air pump test, sample probe was cleaned for intermittent sample aspiration errors, flushed sample probe with bleach, water, and air to clear any clogs, and performed sample and reagent probe alignments.After the troubleshooting actions, the cse ran service verification kit (svk) and tnih qualification protocol with cardiac base pool and performance was within acceptable limits on all materials.The cause of the falsely elevated tnih result is unknown.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; registration #: 3008494306; neuwiesenstrasse 4; beringen 8222 ; WZ 8222
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 23836310
• Report Number: 2432235-2025-00319
• Device Sequence Number: 5081074
• 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): 12/18/2025

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: 11/24/2025
• Initial Report FDA Received Date: 12/18/2025
• 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: 73 YR
• Patient Sex: Female