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	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2024-00098 on 15-may-2024.Additional information (16-may-2024): in addition to the service activities provided in the initial report, the customer service engineer (cse) replaced the wash block and the resuspend injector.Precision testing was performed, and all results were found to be acceptable.Siemens further evaluated the event and concluded that reagent issues can be ruled and the service activities in the initial report and this report returned the instrument to normal operation.The investigation conclusions code was updated to reflect the additional information.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported a falsely elevated high-sensitivity troponin i (tnih) result that was obtained on 1 patient sample on a advia centaur cp instrument.The erroneous tnih result was reported to the physician(s).The patient was redrawn, and the repeat result was lower than the erroneous result.The initial sample was repeated on the same instrument and obtained the same initial value.The repeat result was reported, as the correct result, to the physician(s).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 to report a falsely elevated high-sensitivity troponin i (tnih) result was obtained on 1 patient sample on an advia centaur cp instrument.Quality controls (qcs) recovered within ranges on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse performed a visual inspection, checked the error log, the cse performed a total service protocol and found the rinse block leaking.The rinse block was replaced.The aspirate and dispense, dark count and contamination were checked.A 10-patient sample precision run was performed, and one patient outlier was observed.The cse returned on a subsequent visits and performed a decontamination, replaced all consumables, pump tubing and the waste tubing connector.The instrument was primed, and a 10-patient sample precision run was performed, and all results were found to be acceptable.The cause of the event 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; gewerbestrasse 6; registration #: 3008494306; neuhausen am rheinfall 8212 ; SZ 8212
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 19319224
• Report Number: 2432235-2024-00098
• Device Sequence Number: 6320501
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: 00630414523286
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 06/07/2024

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: 04/22/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2022
• 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: 50 YR
• Patient Sex: Female