MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CA 19-9 (CA19-9); CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING, MANAGEMENT OF PANCREATIC CANCER

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	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports advia centaur xpt ca19-9 lot 535 discordant (elevated) result relative to alternate method testing.The alternate method testing is considered correct.It is unknown if the initial result was reported to the physician.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with these observations.
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer reported an observation of a discordant (elevated) advia centaur xpt ca19-9 lot 535 discordant elevated result relative to alternate method testing.The customer believes the alternate test method results to be correct.The customer sent the sample to another laboratory as part of their investigation and result was lower than the advia centaur xpt ca19-9 lot 535 result.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." siemens is investigating.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2024-00418 initial report on 18-sep-2024.Correction: the lot number information documented in mdr 1219913-2024-00418 initial report is incorrect.The following sections of this report have been updated from the incorrect lot number 55973535 (535) to correct lot number 91785539 (539): d4, h4.Additional information: siemens investigated an outside of the united states (ous) customer complaint for advia centaur ca 19-9.Initial results did not match alternate test method results.There were no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment resulting from the observed result discordance.As stated in the advia centaur ca 19-9 instructions for use (ifu): "the concentration of ca 19-9 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the assay for ca 19-9 used.Values obtained with different assay methods cannot be used interchangeably.If, in the course of monitoring a patient, the assay method used for determining serial levels of ca 19-9 is changed, the laboratory must perform additional serial testing to confirm baseline values." siemens has determined that the performance of the advia centaur ca 19-9 lot 539 has remained within specifications based on internal testing data.Siemens was unable to further investigate this event because the customer declined to provide any additional information.Customer discontinued use of the advia centaur ca 19-9 assay.No product problem was identified, and no further investigation is required.

• Brand Name: ADVIA CENTAUR CA 19-9 (CA19-9)
• Common Device Name: CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING, MANAGEMENT OF PANCREATIC CANCER
• 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: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 20252011
• Report Number: 1219913-2024-00418
• Device Sequence Number: 20855468
• Product Code: NIG
• UDI-Device Identifier: 00630414574028
• UDI-Public: (01)00630414574028(10)91785539(17)250302
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K031393
• 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
• Report Date (Section B): 01/21/2025

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: 03/02/2025
• Device Model Number: N/A
• Device Catalogue Number: 10491244
• Device Lot Number: 91785539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 01/21/2025
• Date Device Manufactured: 05/02/2024
• 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 Sex: Unknown