MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CI 1900 ANALYZER

Model Number	ATELLICA CI 1900 ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that erroneously elevated sodium (na) results on two samples from the patient on the atellica ci 1900 analyzer.The initial result was reported to the physician and questioned.The sample was repeated on an alternate atellica ci 1900 analyzer.The repeat result recovered lower than the initial results and matched the patient¿s clinical history.The repeat results were considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated na results.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens customer care center (ccc) regarding erroneously elevated sodium (na) results on two samples from the patient obtained on the atellica ci 1900 analyzer.Quality control (qc) recovered out of range when run after the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse inspected the instrument and replaced the sensor, integrated multisensor technology (imt) manifold, and performed a power flush.Siemens reviewed the instrument data and determined that a clog or obstruction was present within the imt module, which was removed post-service.Siemens further evaluated the event and determined that the cause of the falsely elevated na results was due to the malfunctioned integrated multisensor technology (imt) module.The instrument is performing according to specifications.No further evaluation is required.

• Brand Name: ATELLICA CI 1900 ANALYZER
• Common Device Name: ATELLICA CI 1900 ANALYZER
• 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.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 25110019
• Report Number: 2432235-2026-00102
• Device Sequence Number: 9219620
• Product Code: JJE
• UDI-Device Identifier: 00630414229553
• UDI-Public: (01)00630414229553
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/07/2026

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 CI 1900 ANALYZER
• Device Catalogue Number: 10947347
• 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: 04/15/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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