MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM CA 19-9 ASSAY; SYSTEM, TEST, CA19-9, FOR MONITORING AND 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	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer from outside the united states reports observation of a discordant result for a sample from a patient when running ca 19-9 lot 522 on atellica im 1600 analyzer.The initial result was reported to the physician(s) who questioned the result.The sample was repeated on another atellica im 1600 analyzer and comparable result was obtained.The numerical result for the alternate method and the reference range were not provided.However, the customer stated that the alternate method result was normal.Data from the customer's analyzers in (b)(6) 2023 indicates they tested over 5,000 samples with the atellica im ca 19-9 assay, where the average recovery of the sample was = 37 u/ml, so the sample make up less than 0.5% of the normal samples tested in july.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.The limitations section of the atellica im ca 19-9 ifu states, "elevated levels of ca 19-9 can be observed in patients with nonmalignant diseases.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." based on the available information, the cause of the discordant result is consistent with normal assay performance.The customer is operational.
Event or Problem Description
The customer from outside the united states reports observation of a discordant result for a sample from a patient when running ca 19-9 lot 522 on atellica im 1600 analyzer.The initial result was reported to the physician(s) who questioned the result.The sample was repeated on another atellica im 1600 analyzer and comparable result was obtained.The numerical result for the alternate method and the reference range were not provided.However, the customer stated that the alternate method result was normal.There are no known reports of patient intervention or adverse health consequences due to the discordant, ca 19.9 result.

• Brand Name: ATELLICA IM CA 19-9 ASSAY
• Common Device Name: SYSTEM, TEST, CA19-9, FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney st.; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17804974
• Report Number: 1219913-2023-00218
• Device Sequence Number: 6691482
• Product Code: NIG
• UDI-Device Identifier: 00630414598178
• UDI-Public: 00630414598178
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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
• Report Date (Section B): 09/23/2023

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: 08/28/2023
• Initial Report FDA Received Date: 09/23/2023
• 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