MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH; ATELLICA CH CARBON DIOXIDE, CONCENTRATED (CO2_C)

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer reported that out-of-range quality control (qc) results and an erroneously depressed patient result were obtained with atellica ch carbon dioxide, concentrated (co2_c).Siemens reviewed the instrument data and the information provided by the customer.Siemens observed issues with signal values of calibration which was associated with poor water quality.Subsequent calibrations and qc results recovered within expected ranges.Return of the patient sample for internal testing was not required.Based on the information provided, siemens determined that the cause of the co2_c low recovery was potentially due to poor water quality produced by the laboratory¿s distilled water system.The issue was resolved following maintenance of the distilled water system and a valid calibration.No product problem was identified.The customer is operational, and no further actions are required.Note: siemens does not provide, or service distilled water systems for the atellica ch in the united states.
Event or Problem Description
The customer reported that out-of-range quality control (qc) results and an erroneously depressed patient result were obtained with atellica ch carbon dioxide, concentrated (co2_c), lot# 150174.The erroneously depressed result was reported to the physician(s), who did not question the result.The same sample was repeated on the original analyzer and obtained a higher result which was considered correct based on the clinical expectation of the affected patient.A corrected report was issued to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the reported event.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH CARBON DIOXIDE, CONCENTRATED (CO2_C)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 23476485
• Report Number: 2432235-2025-00287
• Device Sequence Number: 10227724
• Product Code: KHS
• UDI-Device Identifier: 00630414595900
• UDI-Public: (01)00630414595900(10)150174(17)260414
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K100289
• 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): 11/05/2025

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 Expiration Date: 04/14/2026
• Device Model Number: N/A
• Device Catalogue Number: 11097521
• Device Lot Number: 150174
• 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: 10/11/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown