MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1600 ANALYZER

Model Number	ATELLICA IM 1600 ANALYZER
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center to report falsely depressed cancer antigen ca 19 9 (ca 19 9) results were obtained on a patient sample on atellica im 1600 analyzer.Quality controls (qcs) recovered out of ranges on the day prior and the day after the date of the event.The millipore qguard was changed, a new calibration and qc were performed and were within acceptable ranges.Siemens investigated the event and reviewed the customers bio-rad inteliq tumor marker qc level 3, which showed some imprecision in the pack-to-pack variability.The autocheck data for the analyzer was reviewed and was within acceptable limits but the water pressure was low within range and the wash probe vacuum was high with separation between the aspirate probes.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse replaced the vacuum regulator, water pressure pump, water pressure transducer, sensor, water line piping, wash probes, pinch tubes and wash ring manifold.The cse calibrated the vacuum and recalibrated ca19-9 following service and qc recovered within ranges.A 5-day precision study was conducted to confirm repeatability and within-laboratory precision on the atellica im analyzer using multiple ca19-9 reagent lots.Testing included bio-rad liquichek tumor marker control levels 1¿3 as well as three serum samples.All samples met acceptance criteria for both repeatability and within-lab precision across all reagent lots.These results confirm that the precision performance of the atellica im ca19-9 assay remains consistent with historical expectations.Siemens further evaluated the event and could not determine the potential cause of the falsely depressed ca19-9 patient results due to the replacement and servicing of multiple parts which is considered normal troubleshooting activities.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported falsely depressed cancer antigen ca 19 9 (ca 19 9) results were obtained on a patient sample on an atellica im 1600 analyzer.The erroneous results were not reported to the physician(s).The sample was repeated on an alternate atellica im analyzer.The repeat result was higher than the erroneous results.The repeat result from the initial atellica im analyzer was reported, as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed ca 19-9 results.

• Brand Name: ATELLICA IM 1600 ANALYZER
• Common Device Name: ATELLICA IM 1600 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd; registration #: 2247117; flanders NJ 07836
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 24483016
• Report Number: 2432235-2026-00063
• Device Sequence Number: 5092202
• Product Code: JJE
• UDI-Device Identifier: 00630414002026
• UDI-Public: (01)00630414002026
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K151792
• 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): 02/27/2026

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 Model Number: ATELLICA IM 1600 ANALYZER
• Device Catalogue Number: 11066000
• 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: 02/02/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female