MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CI 1900 ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported a falsely low calcium (ca_2) test result was obtained from an atellica ci analyzer.A siemens regional support specialist (rsc) investigated the reported issue and found a dilution arm error occurred on that sample, but there was no flag on the worklist.It was also found that power was being cut to the dilution arm motors by the cover interlock switches when the covers were opened.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the analyzer.The cse replaced the dilution probe due to signs of wear and gel on the tip.The cse ran an auto check for the dilution arm with acceptable results.The cse ran an extended leak check and liquid level sense reliability test with acceptable results.The cse ran a full auto check with acceptable results.The cause of the falsely low calcium (ca_2) test result is unknown.Dilution probe wear and mechanical issues are contributing factors.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.
Event or Problem Description
The customer reported a falsely low calcium (ca_2) test result was obtained from an atellica ci analyzer.The initial test result was released to a physician who questioned the result.The same sample was repeated twice on the same analyzer.The repeat results were higher and released to a physician as the correct test results.The customer indicated there were no error flags on the test results.There are no known reports of patient intervention, or adverse health consequences due to the event.

• Brand Name: ATELLICA CI 1900 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: 24533877
• Report Number: 2432235-2026-00070
• Device Sequence Number: 16045337
• Product Code: JJE
• UDI-Device Identifier: 00630414229553
• UDI-Public: (01)00630414229553
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K222116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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: 10947347
• 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: 02/18/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown