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

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	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported they obtained erroneously elevated carbon dioxide, concentrated (co2_c, lot 150010) results on sixty-one (61) patient samples on an atellica ch 930 analyzer.The erroneously elevated results were reported to the physician(s), and the results were not questioned.The same samples were reprocessed on alternate atellica ch 930 analyzers s/n (b)(6) and s/n (b)(6).Lower results were obtained, considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated co2_c results.
Additional Manufacturer Narrative
An outside the united states customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding erroneously elevated carbon dioxide, concentrated (co2_c) results on sixty-one (61) patient samples on an atellica ch 930 analyzer.Siemens healthcare diagnostics service operations support (sos) evaluated the information provided by the customer, the available instrument data and concluded the investigation of the event.Sos determined that the probable cause of the elevated co2_c results generated on (b)(6) 2025 is an atypical pack calibration performed on (b)(6) 2025.Quality control (qc) was out of range after this calibration.The atypical calibration was not manually invalidated by the operator and was used on (b)(6) 2025.The co2_c pack was discarded by the customer.The cause of the atypical calibration is unknown.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.

• Brand Name: ATELLICA CH CARBON DIOXIDE, CONCENTRATED (CO2_C)
• Common Device Name: CARBON-DIOXIDE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive, po box 6101; registration # 2517506; newark DE 19714 6101
• Manufacturer Contact: eiman sulieman ; 511 benedict ave.; tarrytown, NY 10591 ; 7372808688
• MDR Report Key: 23604315
• Report Number: 2432235-2025-00295
• Device Sequence Number: 9849190
• Product Code: KHS
• UDI-Device Identifier: 00630414595900
• UDI-Public: (01)00630414595900(10)150010(17)260113
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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: 01/13/2026
• Device Model Number: N/A
• Device Catalogue Number: 11097521
• Device Lot Number: 150010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2025
• 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