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

Model Number N/A

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted siemens healthcare diagnostics to report a discordance in results where the advia centaur xpt cea result was depressed and the alternate test method result was elevated.Calibration and quality control results were acceptable.Based on the information provided to date, siemens's initial investigation indicates that a potential cause of the difference in results between advia centaur xpt cea and alternate method results is the cross-reacting antigen2 (nca2).The table in the expected values section of the advia centaur xpt cea instructions for use (ifu) indicates 37.6% of the time, patients with colorectal cancer had cea values 0 - 2.5 ng/ml, therefore, it is not uncommon for colorectal cancer patients to have advia centaur xpt cea values < 2.5 ng/ml.Additionally, the specificity section of the advia centaur xpt cea ifu states that "nca and nca2 showed minimal interference with the recovery of cea from the serum samples.Average recovery is greater than 95%", which indicates nca2 does not cross react with the advia centaur xpt assay, however the instructions for use of one of the alternate methods used indicates a potential cross reaction with nca2, also referred to as meconium antigen.The interpretation of results section of the ifu states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the limitations section of the ifu states: "do not interpret levels of cea as absolute evidence of the presence or the absence of malignant disease.Measurements of cea should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation.The concentration of cea in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, calibration, and reagent specificity.Cea determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity." siemens is investigating this issue.

Event Description

The customer obtained a depressed advia centaur xpt cea result for a patient sample.The sample was retested using an alternate test method and the result was higher.The customer contacted siemens because of the difference in results.It has not been confirmed which result is true.However; complaint information indicates that the physician believed that the depressed advia centaur xpt cea result was discordant compared the clinical picture of the patient.Additionally, the customer contacted the patient directly for another sample to perform further testing.The sample was obtained approximately a month later and was tested on the same advia centaur xpt instrument as the initial result and the result was also depressed.The sample was tested on alternate methods at non-customer sites and 1 result was high and one result was depressed.There are no known reports of patient intervention or adverse health consequences due to the discordant cea result.

Manufacturer Narrative

Siemens healthcare diagnostics filed mdr 1219913-2022-00219 initial report on 2022-07-22 and mdr 1219913-2022-00219 supplemental 1 report on 2022-08-18.Additional information - 2022-09-01 siemens healthcare diagnostics has concluded the investigation for an outside the united states (ous) customer observation of a depressed advia centaur xpt cea result that was considered discordant compared to alternate methods.The customer had a sample from a colon cancer patient that recovered 2.3 ng/ml on may 12th, 2022 with advia centaur xpt carcinoembryonic antigen (cea) lot 211, which did not agree with a february 2022 value of 12.11 ng/ml generated at another lab with an alternate cea test method.When the patient was tested at a 3rd lab, also using the alternate cea test method, the result was 10.88 ng/ml.For troubleshooting, a new sample from the patient was tested by the customer and recovered 2.1 ng/ml on june 9th with advia centaur xpt carcinoembryonic antigen (cea) lot 211 and when tested at another lab that used the siemens cea assay the sample recovered 1.63 ng/ml.When the sample was sent to another lab and tested with a different alternate cea method, the result was 13.3 ng/ml.There is no information indicating the medications the patient was taking would interfere with the advia centaur xpt cea assay.There is no sample that can be sent to siemens healthineers for evaluation.Siemens reviewed the calibration and control data provided and there is no evidence of a problem.The expected values section of the advia centaur xp/xpt cea instructions for use (ifu) (10629830) indicates that 37.6% of samples from patients with colorectal cancer recovered between 0 - 2.5 ng/ml, so it is not uncommon for colorectal cancer patients to have serum cea values < 2.5 ng/ml.As stated in the limitations section of the ifu: " do not use the advia centaur cea immunoassay as a screening test for diagnosis." "the concentration of cea in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, calibration, and reagent specificity.Cea determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity." the interpretation of results section of the ifu states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the specificity section of the ifu indicates nca2 does not cross react with the assay, however the alternate cea test method used to generate the 12.11 ng/ml and 10.88 ng/ml results indicates this assay does cross react with nca2, also referred to as meconium antigen.The cause of the discrepant results seen by the customer with samples from this one patient when using advia centaur xpt cea kit lot 211 could not be determined but siemens cannot rule out pre-analytical factors, a sample issue, or normal assay performance.Based on the investigation, no product problem was identified.The customer is operational.In section h6, investigation finding and investigation conclusion codes were updated based on the investigation results.

Manufacturer Narrative

Siemens healthcare diagnostics filed mdr 1219913-2022-00219 initial report on 2022-07-22 reporting that an outside the united states customer observed a depressed advia centaur xpt cea result that was considered discordant to alternate methods.Additional information - 2022-07-27 siemens requested clarification of results and section b6 of this report was updated with the clarification and supersedes the data in section b6 of mdr 1219913-2022-00219 initial report filed on 2022-07-22.Siemens continues to investigate.

• Brand Name: ADVIA CENTAUR XPT CEA
• Type of Device: CARCINOEMBRYONIC ANTIGEN IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney street; east walpole, MA 02032
• MDR Report Key: 15089671
• MDR Text Key: 302028586
• Report Number: 1219913-2022-00219
• Device Sequence Number: 1
• Product Code: DHX
• UDI-Device Identifier: 00630414177304
• UDI-Public: 00630414177304
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K200215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: N/A
• Device Catalogue Number: 10309977
• Device Lot Number: 211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability