MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CEA; SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer reported observation of an elevated carcinoembryonic antigen (cea) result which was discordant relative to repeat testing on the same advia centaur cp analyzer.Siemens healthcare diagnostics has concluded the investigation of the event.Siemens has evaluated the instrument data and information provided by the customer.The sample was checked for integrity and no fibrin or hil interference was present.Reagent or instrument issues were ruled out based on quality control (qc) recovery within acceptable ranges, sample results were repeatable, and no issues were reported with other patient samples.Based on the available information, the cause of the discordant result could not be determined.A product problem has not been identified.
Event or Problem Description
The customer reports observation of an elevated advia centaur carcinoembryonic antigen (cea) result for one patient which was discordant relative to repeat testing.The initial elevated result was reported to the physician.The same sample was retested on the original analyzer and produced a lower result.This lower repeat result matched the patient's lab history for cea, and was reported as correct.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated cea result.

• Brand Name: ADVIA CENTAUR CEA
• Common Device Name: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration# 1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 19221923
• Report Number: 1219913-2024-00302
• Device Sequence Number: 17896751
• Product Code: DHX
• UDI-Device Identifier: 00630414177304
• UDI-Public: 00630414177304
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200215
• 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): 05/01/2024

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 Expiration Date: 10/20/2024
• Device Model Number: N/A
• Device Catalogue Number: 10309977
• Device Lot Number: 219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 05/01/2024
• Date Device Manufactured: 10/20/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female