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	02/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens remote services center (rsc) and reported observation of an elevated atellica im ca 19-9 result which was discordant relative to repeat testing on an alternate method.The assay's instructions for use (ifu) states the following, under expected values section: ¿3.7% of samples from normal patients recovered >37 iu/ml so a certain number of elevated results from normal patients can be expected for this assay.¿ the assay's instructions for use (ifu) states the following, under limitations section: ¿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.¿ siemens further evaluated the event and determined that the sample-specific issue contributed to the elevated ca 19-9 result.A product issue was not identified.The customer is operational and the reported event was resolved by routine troubleshooting.
Event or Problem Description
The customer reports observation of an elevated atellica im ca 19-9 result with lot# 549, which was discordant relative to repeat testing on an alternate method.The initial result was not reported to the physician(s).The same sample was repeated on the original analyzer, which produced similarly elevated result.The sample was then repeated on an alternate atellica instrument and obtained similar elevated result and considered correct.The sample was tested on the alternate method which produced a lower result.The repeat result obtained on the alternate method was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Correction (09-mar-2026): in the initial report under the b6 section, the sentence ¿the sample was then repeated on an alternate atellica instrument and obtained similar elevated result and considered correct.¿ was entered incorrectly.Please find the corrected sentence for b6 section below: "the sample was then repeated on an alternate atellica instrument and obtained similar elevated result and was considered erroneous.Both repeat results were not reported to the physician(s).".

• 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. e; registration #: 1219913; 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: 24504542
• Report Number: 1219913-2026-00049
• Device Sequence Number: 18609460
• Product Code: NIG
• UDI-Device Identifier: 00630414598161
• UDI-Public: (01)00630414598161(10)85824549(17)260502
• 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,Followup
• Report Date (Section B): 03/09/2026

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: 05/02/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995489
• Device Lot Number: 85824549
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2025
• 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: 26 YR
• Patient Sex: Female