MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CA 15-3; SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of depressed advia centaur ca 15-3 results which were discordant relative to alternate-method testing.No issues were identified with assay calibration or quality control (qc) results siemens is evaluating.
Event or Problem Description
The customer reports observation of depressed advia centaur ca 15-3 results which were discordant relative to alternate-method testing when using ca 15-3 lot 218.A ca 15-3 result below cutoff was obtained for a female patient with metastatic cancer.When this sample was repeat-tested for troubleshooting purposes, the low result was reproduced.The patient was re-tested at a hospital, using abbott alinity, and a much higher result was obtained.Additional re-testing using the same method in a private lab produced a similar elevated result.The higher results were considered believable by the physician, and the advia centaur ca 15-3 results were identified as falsely depressed.There are no allegations of patient harm or any other adverse consequences in association with the observed discordance.
Additional Manufacturer Narrative
Testing dates in section h6 had initially been erroneously reported as "2024".January test dates have been corrected to "2025".
Additional Manufacturer Narrative
A customer from outside the united states reported observation of depressed advia centaur ca 15-3 results which were discordant relative to alternate-method testing.Mdr 1219913-2025-00024 was initially submitted on 18-jan-2025.Update, 28-jan-2025: siemens has concluded investigation.Assay calibration and quality control (qc) data were reviewed, and no issues were identified.The limitations section of the assay¿s instructions for use (ifu) warns of the possibility of heterophilic antibody interference.The sample in question was not available to be returned for investigational testing, and request for a patient re-draw for additional testing was denied.No testing for endogenous interferents could be performed.Based on the available information, a specific cause for the discordant result could not be determined.However, no product problem was identified.The customer is operational, and the reported issue was resolved by routine troubleshooting.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ADVIA CENTAUR CA 15-3
• Common Device Name: SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration no. 1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 21185628
• Report Number: 1219913-2025-00024
• Device Sequence Number: 17218312
• Product Code: MOI
• UDI-Device Identifier: 00630414574257
• UDI-Public: (01)00630414574257(17)24963543(17)250608
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K012357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2025

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: 05/07/2025
• Device Model Number: N/A
• Device Catalogue Number: 10327620
• Device Lot Number: 82015218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 01/21/2025; 01/28/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 01/21/2025; 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• 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 Sex: Female