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

Model Number N/A

Device Problem Low Test Results (2458)

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

Event Date 04/24/2022

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported a falsely depressed carcinoembryonic antigen (cea) patient sample result that was obtained on an advia centaur cp instrument.The result was considered to be discordant with the repeat testing on the same instrument and on the advia centaur xpt at an alternate site.Siemens is investigating the issue.The limitations section of the instructions for use states: "note: 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.".

Event Description

A falsely depressed carcinoembryonic antigen (cea) result was obtained on a patient sample on an advia centaur cp instrument.The falsely depressed result was not reported to the physician(s).On the following day, (b)(6) 2022, the sample was repeated at an alternate lab on an advia centaur xpt instrument.The sample was then diluted 1:10 and repeated on the initial instrument.The result was higher than the initial discordant result.On (b)(6) 2022, the sample was repeated on the initial instrument and the result recovered at >100 ng/ml.The repeat result from the alternate instrument was reported as the correct result, to the physician.The higher results were considered correct.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed cea result.

Manufacturer Narrative

The initial mdr 1219913-2022-00153 was filed on may 20, 2022.Additional information - june 3, 2022: an outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported a falsely depressed carcinoembryonic antigen (cea) patient sample result that was obtained on an advia centaur cp instrument.The result was considered to be discordant with the repeat testing on the same instrument and on the advia centaur xpt at an alternate site.The sample recovered 90.4 ng/ml when tested with advia centaur cp carcinoembryonic antigen (cea) kit lot 209 but when tested at another lab the advia centaur xpt cea result was 510 ng/ml.When the sample was repeated at the customer site undiluted it recovered >100 ng/ml and when diluted 1/10 with an unknown liquid, not cea diluent, the result was 584 ng/ml after being corrected for the dilution.The patient had high results for bilirubin and liver enzymes but values were not provided.Siemens reviewed the control data provided and there is no evidence of a problem.Based on the information available, no product problem was identified.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ADVIA CENTAUR CP CARCINOEMBRYONIC ANTIGEN (CEA)
• Type of Device: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
• 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: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 14466094
• MDR Text Key: 300354178
• Report Number: 1219913-2022-00153
• Device Sequence Number: 1
• Product Code: DHX
• UDI-Device Identifier: 00630414177304
• UDI-Public: 00630414177304
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2022
• Device Model Number: N/A
• Device Catalogue Number: 10309977
• Device Lot Number: 209
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2021
• 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