MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM CA 19-9; SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), MONITORING, MANAGEMENT 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	10/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reports observation of a discordant, elevated atellica im ca19-9 result for a patient which disagreed with the clinical pictures of the patient and with alternate method testing.The discordant result was not reported to the physician.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed discordance.
Additional Manufacturer Narrative
An outside of the united states (ous) customer obtained a sample result that recovered higher with atellica im ca 19-9 lot 528 than with 2 alternate methods and also disagreed with the clinical picture of the patient.Siemens investigated the event, which included an assessment of reagent, instrument, and sample data.Reagent and instrument issues were ruled out based on quality control (qc) results that were within acceptable ranges, and there were no issues reported with other patient samples.When the sample was treated with a heterophilic blocking tube (hbt) and tested with the atellica im ca 19-9 assay, the result dropped indicating that heterophilic antibodies are elevating the results with the atellica im ca 19-9 assay.The limitations of procedure section of the heterophilic blocking tube instructions for use (ifu) states, "there may be some samples with extremely strong heterophilic interference.In such cases the hbt may not be able to block all of the assay interference." the limitations section of the atellica im ca 19-9 instructions for use (ifu) states, "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay is designed to minimize interference from heterophilic antibodies.Additional information may be required for diagnosis." "this device is not indicated for screening or the early detection of pancreatic cancer or as a diagnostic tool to confirm the presence or absence of malignant pancreatic disease." the interpretation of results section of the ifu states, "results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings." based on the available information, the cause of the discordant result is consistent with a sample specific interferent.A product performance issue was not identified.

• Brand Name: ATELLICA IM CA 19-9
• Common Device Name: SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), MONITORING, MANAGEMENT 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.; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 18210710
• Report Number: 1219913-2023-00301
• Device Sequence Number: 6255467
• Product Code: NIG
• UDI-Device Identifier: 00630414598161
• UDI-Public: 00630414598161
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/27/2023

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: 03/23/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995489
• Device Lot Number: 528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2023
• Initial Report FDA Received Date: 11/27/2023
• Date Device Manufactured: 05/23/2023
• 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: A
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male