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

Model Number	ATELLICA CI 1900
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely elevated concentrated carbon dioxide (co2_c) result was obtained on a patient sample on an atellica ci 1900 analyzer.The initial result was not reported to the physician(s).The sample was repeated on the original analyzer.The repeat result recovered lower than the initial result.The repeat result was reported as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to a falsely elevated co2_c result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that a falsely elevated concentrated carbon dioxide (co2_c) result was obtained on a patient sample on an atellica ci 1900 analyzer.Quality control (qc) was within acceptable range on the day of the event.Siemens performed a co2_c precision study using both levels of quality control (qc) and patient sample which recovered acceptably.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse inspected the fluidics system for leaks, aligned the reaction washer, ran the auto check for the reaction washer and mixer, performed mix and fluidics studies (atp).The cse replaced valves, inspected tubing(s), connections, and probes with no evidence of leakage; then the cse ran auto check and qc, which recovered acceptably.Next, the cse replaced vacuum valves, all probes in the reaction ring washer and reaction ring cuvettes; reset the wash probe alignments, performed vertical alignment, ran weekly maintenance, and ran drain and fill tests.The cause of the falsely elevated co2_c result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2024-00099 on 15-may-2024.Additional information (26-jun-2024): water or saline introduction into the reaction cuvette during testing may cause elevated concentrated carbon dioxide (co2_c) results.Siemens further evaluated the event and concluded that the introduction of water or saline into the reaction cuvette potentially contributed to the falsely elevated co2_c result.The service activities performed by the customer service engineer (cse), which are described in the initial report, resolved the issue.The investigation conclusions code in section h6 was updated to reflect the additional information.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ATELLICA CI 1900
• Common Device Name: ATELLICA CI 1900
• 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: emmanuella makridakis ; 511 benedict ave.; tarrytown, NY 10591 ; 9086354191
• MDR Report Key: 19321410
• Report Number: 2432235-2024-00099
• Device Sequence Number: 6320072
• Product Code: JJE
• UDI-Device Identifier: 00630414229553
• UDI-Public: 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,Followup
• Report Date (Section B): 07/02/2024

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
• Device Catalogue Number: 10947347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2023
• 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: 61 YR
• Patient Sex: Female