MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1600 ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

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	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states customer (ous) contacted siemens to report that a falsely elevated human chorionic gonadotropin (hcg) test result was obtained from an atellica im 1600 analyzer.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the analyzer.The cse found that aspiration probe 1 was clogged.The cse replaced the aspirate 1 probe.Quality control (qc) materials were run with acceptable results.The cause of the falsely elevated hcg test result was a clogged aspiration probe 1.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.
Event or Problem Description
A falsely elevated human chorionic gonadotropin (hcg) test result was obtained from an atellica im 1600 analyzer.The quality control (qc) material run prior to the sample was unacceptable.It is unknown if the initial test result was released to a physician.An alternate sample was tested on an alternate atellica im 1600 analyzer.The test result from the alternate sample was released to a physician as the correct test result.There are no known reports of patient intervention or adverse health consequences due to the event.

• Brand Name: ATELLICA IM 1600 ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane swords, co.; swords, co.dublin ; EI
• Manufacturer Contact: karl aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 24389264
• Report Number: 2432235-2026-00057
• Device Sequence Number: 10208523
• Product Code: JJE
• UDI-Device Identifier: 00630414002026
• UDI-Public: (01)00630414002026
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 02/19/2026

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: N/A
• Device Catalogue Number: 11066000
• Device Lot Number: N/A
• 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: 01/30/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female