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

Model Number	ADVIA CENTAUR CP
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A falsely elevated high sensitivity troponin i (tnih) result was obtained on a patient sample on an advia centaur cp instrument.The erroneous result was not reported to the physician(s).The sample was repeated twice on the original instrument.The repeat results recovered lower than the erroneous result.The repeat result of 8.05 ng/ml was reported to the physician(s) as correct result.On (b)(6) 2024, the customer sent out the same sample to a reference lab for testing, and the sample recovered with 7.0 ng/ml and 7.0 ng/ml was considered correct.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated tnih result.
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) result was obtained on a patient sample on an advia centaur cp instrument.Quality control (qc) was acceptable at the time of sample processing.The customer also noticed extra fluid in the solid waste drawer and bubbles in the aspirate probe tubing.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse inspected the instrument, replaced grey pump tubing, verified proper aspiration at all aspiration probes and luminometer waste probe, primed the instrument, and calibrated the aspiration probe bubble detector.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
• Common Device Name: ADVIA CENTAUR CP
• 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: christina lam ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 18584344
• Report Number: 2432235-2024-00017
• Device Sequence Number: 7021490
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: 00630414523286
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/25/2024

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
• Device Catalogue Number: 10309710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 01/25/2024
• 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