MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM CA 19-9

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	06/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported observation of elevated atellica im ca 19-9 results when using lot# 546 which were discordant relative to repeat testing on an alternate method.An initial elevated atellica im ca 19-9 result was obtained for the patient in question.The same sample was repeated on the original analyzer and obtained a similarly elevated result.The initial elevated result was reported to the physician(s), who questioned the result.The same sample was tested after peg6000 (polyethylene glycol 6000) treatment on the same analyzer for troubleshooting purposes and obtained a lower result.Then the sample was also retested using an alternate test method (beckman coulter unicel dxi 800) which obtained a much lower result.The lower result obtained using the alternate method was considered correct based on the clinical picture of the affected patient and a corrected report was issued to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens remote services center (rsc) and reported observation of elevated atellica im ca 19-9 results which were discordant relative to repeat testing on an alternate method.Siemens reviewed the instrument data and the data provided by the customer.Reagent and instrument issues were ruled out based on quality control (qc) recovery within acceptable ranges and no issues were reported with other patient samples.Siemens observed that pretreatment of the sample with peg6000 may have precipitated antibodies that were interfering with the atellica im ca 19-9 assay.The assay instructions for use (ifu), under expected values section indicates the following: "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 assay instructions for use (ifu), under limitations section states the following: "the assay is not supposed to be used as a screening test or for diagnosis.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.Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays." based on the available information, the cause of the discordant elevated result was consistent with a sample specific interferent.The issue was resolved by routine troubleshooting; a product problem was not identified.The customer is operational, and no further actions are required.

• Brand Name: ATELLICA IM CA 19-9
• Common Device Name: ATELLICA IM CA 19-9
• 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22402523
• Report Number: 1219913-2025-00134
• Device Sequence Number: 15527372
• Product Code: NIG
• UDI-Device Identifier: 00630414598161
• UDI-Public: (01)00630414598161(10)88041546(17)250919
• 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): 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): 07/04/2025

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: 09/19/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995489
• Device Lot Number: 88041546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2024
• 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 Age: 34 YR
• Patient Sex: Female