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	05/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer reported that falsely elevated high-sensitivity troponin i (tnih) results were obtained on multiple patient samples on an atellica ci 1900 analyzer.Quality control (qc) recovered within the range before the erroneous results were obtained.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse inspected the instrument, replaced wash probe 2 manifold, ran auto check, qc and precision, which passed.Siemens further evaluated the event and determined that the probable cause of the falsely elevated tnih results could not be determined.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that falsely elevated high-sensitivity troponin i (tnih) results were obtained on multiple patient samples on an atellica ci 1900 analyzer.The initial results were reported to the physician(s), who questioned the results.The samples were reprocessed on the alternate atellica ci 1900 analyzer.The repeat results were consistent with the patient¿s clinical history.The repeat results were reported as correct results to the physician(s).It is unknown whether there were any known reports of patient intervention due to this event, however, no harm or adverse health consequences to the patient were alleged.

• Brand Name: ATELLICA CI 1900 ANALYZER
• Common Device Name: ATELLICA CI 1900 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; 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: 25425257
• Report Number: 2432235-2026-00124
• Device Sequence Number: 9976184
• Product Code: JJE
• UDI-Device Identifier: 00630414229553
• UDI-Public: (01)00630414229553
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/08/2026

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: 05/18/2026
• Initial Report FDA Received Date: 06/08/2026
• 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