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

Model Number	ATELLICA CI 1900 ANALYZER
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely depressed concentrated carbon dioxide (co2_c) result was obtained on a patient sample on an atellica ci 1900 analyzer.The initial result was reported to the physician(s).The sample was repeated on an original atellica ci 1900 analyzer.The repeat results recovered higher than the initial result and were considered correct.It is unknown which repeat result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to a falsely depressed co2_c result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that an atellica ci 1900 analyzer outputted out-of-range quality control (qc) and a falsely depressed concentrated carbon dioxide (co2_c) result on a patient sample.A siemens customer service engineer (cse) was dispatched to the customer site.During this visit, the cse observed flashing lights on the deionized water system and low resistivity readings.The cse performed the service maintenance which recovered the resistivity reading to normal.Further, the cse backlashed and dumped the onboard water tank twice, primed all probes and drains, performed drain, fill, photometer auto-check, and new calibration, and ran qc which recovered acceptably.Siemens evaluated the event and concluded that the poor water quality due to an issue with the deionized water system feeding, addressed with the service actions above, potentially contributed to the falsely depressed co2_c result.The instrument is performing according to specifications.No further evaluation of this device 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: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 20630249
• Report Number: 2432235-2024-00288
• Device Sequence Number: 12802951
• Product Code: JJE
• UDI-Device Identifier: 00630414229553
• UDI-Public: (01)00630414229553
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/07/2024

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 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: 10/19/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2024
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown