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	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) and reported that an erroneously elevated concentrate carbon dioxide (co2_c) result was obtained on a patient sample on the atellica ci 1900 analyzer.The customer noticed that the dilution washer probe 2 was not seated correctly, while cleaning the dilution washer probes, removed thumb screw and found that it was threaded.The customer also noticed droplets were formed at the base of this probe.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse reviewed the system and found that not all maintenance was performed correctly, found excessive buildup on dilution washer probes, inspected the overall cleanliness of the system and washer probes and replaced the aspirate valve on the reaction washer probe 2 for droplet forming.Then, the cse reviewed tubing routing, performed liquid waste drain tests, system auto check and maintenance module, which passed.The customer ran quality control (qc) and replicates on affected assay.The cause of the event is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that an erroneously elevated concentrate carbon dioxide (co2_c) result was obtained on a patient sample on the atellica ci 1900 analyzer.The initial result was reported to the physician(s).The sample was repeated on an alternate atellica ci 1900 analyzer.The repeat result matched the patient's clinical history and was reported as the correct result to the physician(s).There are no known reports of adverse health consequences due to this event.

• 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: 21975044
• Report Number: 2432235-2025-00127
• Device Sequence Number: 9197825
• Product Code: JJE
• UDI-Device Identifier: 00630414229553
• UDI-Public: (01)00630414229553
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

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: 04/11/2025
• Initial Report FDA Received Date: 05/07/2025
• 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 Age: 18 YR
• Patient Sex: Male