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	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that erroneously elevated carbon dioxide (co2, lot#160071) results were obtained on multiple patient samples on an atellica ch 930 analyzer.The initial results were reported to the physician(s) but not questioned.The samples were repeated on the original atellica ch 930 analyzer and obtained lower results which were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated co2 results.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that erroneously elevated carbon dioxide (co2_c) results were obtained on multiple patient samples on an atellica ch 930 analyzer.Siemens reviewed the available instrument data and determined that the co2_c calibration and quality control (qc) recovery patterns were consistent with a water quality issue beginning on 02-sep-2026 and resolving around 20-sep-2026.Quality control (qc) recovery was out of range on the day of the event.The customer performed a co2_c pack calibration (calibration id (b)(4)) following elevated qc recovery, after which qc recovered within the expected range.Siemens' review of calibration, qc, and patient data did not identify evidence of an analyzer or reagent issue.Some samples considered erroneous by the customer were not repeated until over 24 hours after the initial elevated results were obtained.Siemens determined that the lower repeat co2_c results may have been related to prolonged sample exposure to air and/or underfilled sample tubes prior to repeat testing.The specific cause of the water quality issue and the reported event could not be determined but most likely due to prolonged exposure to air prior to repeat testing being performed.The issue was resolved through routine troubleshooting and correction of the water quality condition.The customer is operational.No product issue was identified.The device is performing within specifications.No further evaluation is required.

• 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, po box 6101; registration # 2517506; newark DE 19714 -610
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; +919(870)577433
• MDR Report Key: 50911831
• Report Number: 2432235-2026-00230
• Device Sequence Number: 5330823
• Product Code: KHS
• UDI-Device Identifier: 00630414595900
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/28/2026

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 Model Number: N/A
• Device Catalogue Number: 11097521
• Device Lot Number: 160071
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2026
• 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