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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported the falsely elevated carbon dioxide, concentrated (co2_c) results were obtained on multiple patient samples on an atellica ch 930 analyzer.Quality control (qc) and calibration were acceptable prior to the erroneous results.The customer loaded a new reagent lot and recalibrated the method.Siemens is evaluating the event.
Event or Problem Description
The customer reported that falsely elevated carbon dioxide, concentrated (co2_c) results were obtained on multiple patient samples on an atellica ch 930 analyzer.The erroneous results were reported to the physician(s), who did not question the results.The samples were reprocessed on the original analyzer.The reprocessed results were considered correct and reported 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
Siemens filed the initial mdr 2432235-2026-00071 on 09-mar-2026.Additional information (28-apr-2026): siemens reviewed the information provided by the customer, and the available instrument data files.Siemens' review of the instrument data indicated that there was a gap in testing from the time the original sample was tested until the time the repeat testing was performed.The gap between original testing and repeat testing ranged from between 3 to 8 hours.During this time, it is unknown as to how the sample was stored.Co2_c is susceptible to environmental conditions within the lab.Co2_c calibration data indicated poor co2_c calibrator response recovery during the time the discordant co2_c results had occurred.Co2_c is very sensitive to water quality, and the quality of the water can be gauged using co2_c calibration data response values.Siemens confirmed that the current water resistivity was = 10 mo-cm.Siemens' review of the co2_c qc recovery indicated a possible qc stability issue causing the customer to prematurely calibrate the co2_c method.Siemens evaluated the event and determined that the cause of the behavior is inconclusive due to a number of variables that cannot be ruled out as contributing factors (length of time elapsed between testing of original sample and repeat sample, water quality issues).A product problem was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the siemens investigation.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH CARBON DIOXIDE, CONCENTRATED (CO2_C)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive, po box 6101; 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: 24542916
• Report Number: 2432235-2026-00071
• Device Sequence Number: 15751558
• Product Code: KHS
• UDI-Device Identifier: 00630414595900
• UDI-Public: (01)00630414595900(10)150174(17)260411
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 05/15/2026

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: 02/13/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 05/15/2026
• 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