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

Model Number	ADVIA CENTAUR XP
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A falsely elevated cancer antigen ca 27.29 (br) result was obtained on a patient sample an advia centaur xp instrument.The initial result was provided to the physician(s), who questioned the result.The erroneous result was higher than the patient¿s historical result.Subsequently, the sample was repeated on the same instrument and recovered lower than the erroneous result.The repeat result was reported to the physician(s), as the correct result.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated br result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) to report that a falsely elevated cancer antigen ca 27.29 (br) result was obtained on a patient sample an advia centaur xp instrument.The quality controls (qc) were acceptable on the day of occurrence.Siemens remotely reviewed the instrument¿s event log and found multiple integrity errors for qc and water pressure low errors on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.The cse performed a total service visit (tsv), checked all probes, and replaced the aspirate probe.Then, the customer processed qc, which recovered acceptably.The service activities returned the instrument to normal operation.The cause of the falsely elevated br result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR XP
• Common Device Name: ADVIA CENTAUR XP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; chapel lane, swords co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: douglas stanton ; 511 benedict ave.; tarrytown, NY 10591 ; 9142706592
• MDR Report Key: 18124515
• Report Number: 2432235-2023-00296
• Device Sequence Number: 17818484
• Product Code: JJE
• UDI-Device Identifier: 00630414573564
• UDI-Public: 00630414573564
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K971418
• 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): 11/13/2023

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
• 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: Not provided
• Initial Report FDA Received Date: 11/13/2023
• Date Device Manufactured: 10/04/2015
• 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