MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM CA 19-9 (CA19-9); CA19-9 -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	09/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated patient results when using atellica im ca19-9.The patients resulted higher than 37 u/ml, which was unexpected by the customer as patients had no disease state.The customer did not report the >37 u/ml atellica im ca19-9 results but tested on an alternate test method for comparison and results were lower and considered correct.There are no allegations of patient or user intervention or adverse health consequences due to the elevated ca19-9 results.
Additional Manufacturer Narrative
Siemens completed investigation for an outside of the united states (ous) customer observation of falsely elevated patient results when using atellica im ca19-9 compared to results of an alternate test method.Siemens reviewed customer patient and control data.The average recovery shifted from 12 u/ml to 16 u/ml with the atellica im ca 19-9 assay, which is in line with expected performance.The expected values section of the atellica im ca 19-9 instructions for use (ifu) indicates 3.7% of samples from normal patients recovered >37 u/ml, so a certain number of elevated results from normal patients can be expected for this assay.Data indicates the customer tested 430 samples that recovered < 37 u/ml with the atellica im ca 19-9 assay from 2023/09/16 to 2023/10/02.When compared to the number of samples from 2023/09/16 to 2023/10/02 that recovered > 37 u/ml with the atellica im ca 19-9 assay but < 37 u/ml with the alternate method, the expected values section of the atellica im ca 19-9 ifu is met.The interpretation of results section of the 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." the limitations section of the ifu states: "warning: do not use the atellica im ca 19 9 assay as a screening test or for diagnosis.Do not predict disease recurrence solely on levels of atellica im ca 19 9.Normal levels of atellica im ca 19 9 do not always preclude the presence of disease." "note: do not interpret serum levels of ca 19 9 as absolute evidence of the presence or the absence of malignant disease.Before treatment, patients with confirmed gi carcinoma frequently have levels of ca 19 9 within the range observed in healthy individuals.Additionally, elevated levels of ca 19 9 can be observed in patients with nonmalignant diseases.Measurements of ca 19 9 should always be used in conjunction with other diagnostic procedures, including information from the patient¿s clinical evaluation." "the concentration of ca 19 9 in a given specimen determined with assays from different manufacturers can vary because of differences in assay methods, calibration, and reagent specificity.Ca 19 9 determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity.Therefore, it is important to use assay-specific values to evaluate quality control results." based on the investigation, a product problem was not identified.The product is performing as expected.

• Brand Name: ATELLICA IM CA 19-9 (CA19-9)
• Common Device Name: CA19-9 -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 ; 3392064073
• MDR Report Key: 18026415
• Report Number: 1219913-2023-00274
• Device Sequence Number: 18058771
• Product Code: NIG
• UDI-Device Identifier: 00630414598178
• UDI-Public: 00630414598178
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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
• Report Date (Section B): 10/28/2023

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: 11/03/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995490
• Device Lot Number: 522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 10/27/2023
• Date Device Manufactured: 01/03/2023
• 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