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

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	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer obtained a discordant depressed ca 19-9 result for a male patient sample on advia centaur cp compared to an alternate method.The initial result was reported to the physician(s) who questioned the result.The sample was repeated in a different lab on an unknown method, and the result was higher.A pet scan in december 2019 showed no abnormalities.The interpretation of results section of the advia centaur ca 19-9 instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens healthcare diagnostics is investigating.
Event or Problem Description
The customer obtained a discordant depressed ca 19-9 result for a male patient sample on advia centaur cp compared to an alternate method.The initial result was reported to the physician(s) who questioned the result.The sample was repeated in a different lab on an unknown method, and the result was higher.There are no known reports of patient intervention or adverse health consequences due to the discordant ca19-9 result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2023-00171 on jun 19, 2023.Additional information aug 10, 2023: the customer obtained a discordant depressed ca 19-9 result for a male patient sample on advia centaur cp compared to an alternate method.The initial result was reported to the physician(s) who questioned the result.The sample was repeated in a different lab on an unknown method, and the result was higher.The initial issue was reported as a sample that recovers < 37 u/ml with the advia centaur cp ca 19-9 assay but > 200 u/ml at other sites with alternate ca 19-9 methods.There were no abnormalities in the patient's positron emission tomography (pet) scan, so the advia centaur cp ca 19-9 result is in line with the patient's clinical picture.The customer provided a list of medications and questioned siemens if the medications could be interfering with the advia centaur cp ca 19-9 assay.Siemens does not have any information that would indicate the medications in the list would impact the advia centaur cp ca 19-9 assay.Based on the available information, the advia centaur cp ca 19-9 results are accurate.The customer is operational.Correction: in section d9 - device returned to manufacturer? was checked in error in the initial mdr.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ADVIA CENTAUR CA 19-9 ASSAY
• Common Device Name: CARBOHYDRATE ANTIGEN (CA19-9), MONITORING OF PANCREATIC CANCER
• 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: 17151476
• Report Number: 2432235-2023-00171
• Device Sequence Number: 6021434
• Product Code: NIG
• UDI-Device Identifier: 00630414574257
• UDI-Public: 00630414574257
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 09/01/2023

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: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 10491379
• Device Lot Number: 516
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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: 73 YR
• Patient Sex: Male