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

Model Number	ATELLICA IM 1600 ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
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 elevated total prostate specific antigen (psa), and vitamin b12 (vb12) results were obtained on two patient samples on an atellica im 1600 instrument.A customer service engineer (cse) was dispatched to the customer¿s site.During this visit the cse noticed that the wash ring was full of air bubbles, so the cse inspected the manifold and saw that there were two loose hoses in the block.The cse redid the ends and fitted the hose and also replaced all the tubing of the cleaner line that had damaged connectors.After completing these actions, the cse adjusted the vacuum from 2.3 inhg to 2.45 inhg and processed the autocheck twice; it had no failures.The cse initialized the instrument.Siemens further evaluated the event and concluded that the probable cause of the falsely elevated psa and vb12 results is consistent with damage to the connectors in the cleaner line tubing.The instrument is fully operational.No further evaluation of this device is required.
Event or Problem Description
The customer reported falsely elevated total prostate-specific antigen (psa) and vitamin b12 (vb12) results were obtained on two patient samples on an atellica im 1600 analyzer after evaluating the impact due to an error in the liquid residues.The erroneous results were reported to the physician(s), who questioned the results.The samples were repeated on an alternate atellica im analyzer.There are no known reports of patient intervention or adverse health consequences due to the discordant 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: sumaiya rajpura ; 511 benedict ave.; tarrytown, NY 10591 ; 5513306538
• MDR Report Key: 23967669
• Report Number: 2432235-2026-00004
• Device Sequence Number: 9343533
• Product Code: JJE
• UDI-Device Identifier: 00630414002026
• UDI-Public: (01)00630414002026
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151792
• 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): 01/05/2026

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: 11/18/2025
• Initial Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2018
• 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 Sex: Unknown