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

Model Number	ADVIA CENTAUR XP ANALYZER
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported falsely depressed cancer antigen 19-9 (ca 19-9) results were obtained on two patient samples on an advia centaur xp analyzer.The siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse noted there was a grinding noise coming from the in-process queue when the sample probe was moved into position.The cse performed a full system check and probe calibrations.The cse discovered that there was gunk stuck on the rails of the in-process queue, causing the queue to not go into position completely and causing the noise.The cse cleaned and lubricated the rails and performed in-process queue by moving the racks in and out with no errors.Then, the cse replaced connectors, ran dry, wet water and wet wash, decontaminated acid base and ran quality control.The cause of the falsely depressed ca 19-9 results is unknown.The analyzer is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Falsely depressed cancer antigen 19-9 (ca 19-9) results on two patient samples were obtained on an advia centaur xp analyzer.The initial results were not reported to the physician(s).The samples were repeated on the same instrument with 1:10 dilution.The second repeat results were considered correct and reported to the physician(s).There are no known reports of patient interventions or adverse health consequences due to the falsely depressed ca 19-9 results.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2023-00313 on 30-nov-2023.Additional information (05-dec-2023): in addition to the service actions mentioned in the initial report, the cse performed the sample probe alignment and inspected the sample probe motors.The cse performed the in-process queue test and found no grinding noise and no sample probe vertical movement error.Siemens further evaluated the event and concluded that the sample probe's vertical movement error was due to the bearing jammed in the in-process queue which was resolved by lubricating the bearing in the in-process queue.The cause of the falsely depressed cancer antigen 19-9 (ca 19-9) results is due to the wash 1 dispense issue which was resolved by replacing the wash1 connector.The instrument is operational.The investigation conclusions code in section h6 was updated to reflect the additional information.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR XP ANALYZER
• Common Device Name: ADVIA CENTAUR XP ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: eric so ; 511 benedict ave.; tarrytown, NY 10591
• MDR Report Key: 18240104
• Report Number: 2432235-2023-00313
• Device Sequence Number: 3225693
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: 00630414573564
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/27/2023

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 XP ANALYZER
• Device Catalogue Number: 10364455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2010
• 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