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

Model Number	ATELLICA CI ANALYZER
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated concentrated carbon dioxide (co2_c) results were obtained on 7 patient samples on an atellica ci analyzer.The erroneous results were not reported to the physician(s).The samples were repeated on the same atellica ci analyzer.The repeat results were lower than the erroneous results.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely elevated co2_c results.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center to report falsely elevated concentrated carbon dioxide (co2_c) results were obtained on 7 patient samples on an atellica ci analyzer.Quality controls (qcs) recovered out of ranges on the day of the event.The customer was running the analyzer on a temporary water filter source and the water quality was found to be unacceptable.Siemens further evaluated the event and determined that poor water quality (low resistivity) potentially contributed to the elevated co2_c results.The customer performed maintenance on the water system and no further erroneous results were obtained.The event is due to a use error.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ATELLICA CI ANALYZER
• Common Device Name: ATELLICA CI ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; chapel lane, swords co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: kristin kehyaian ; 511 benedict ave.; tarrytown, NY 10591 ; 9148267101
• MDR Report Key: 21876167
• Report Number: 2432235-2025-00117
• Device Sequence Number: 7766068
• Product Code: JJE
• UDI-Device Identifier: 00630414229553
• UDI-Public: (01)00630414229553
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/21/2025

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 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: 03/29/2025
• Initial Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2024
• 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