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	04/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that erroneously elevated carbon dioxide, concentrated (co2_c) results were obtained on two patient samples on an atellica ch 930 analyzer.The erroneous results were reported to the physician(s), who questioned the results.The samples were reprocessed on the original analyzer.The reprocessed results were lower than the erroneous results.The reprocessed results were reported as the correct results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated carbon dioxide, concentrated (co2_c) results.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens remote services center (rsc) and reported that erroneously elevated carbon dioxide, concentrated (co2_c) results were obtained on two patient samples on an atellica ch 930 analyzer.Quality control (qc) was out of range on the day of the event.Siemens concluded the investigation of the event.Siemens reviewed the available instrument data files, and the information provided by the customer.The affected samples were processed using reagent well 1.The erroneous results were generated using calibration id (cal id) 13680, while the correct results were generated using cal id 13687.The calibrations were automatically accepted by the system because the software setting for the calibration acceptance criteria, ¿qc must be within range,¿ was not enabled.Siemens¿ review of calibrator response recovery for the co2_c calibrations performed at the time of the event indicated atypical calibrator response recovery, which shifted the co2_c calibration curve and increased all results on two different co2_c reagent wells.The customer performed a new pack calibration on reagent well 1 on (b)(6) 2026, which recovered atypical calibrator response recovery and elevated co2_c qc.The customer then immediately repeated the calibration on reagent well 1 and reagent well 0, which also recovered atypical calibrator response recovery and elevated co2_c qc.Later, the customer performed acceptable calibrations on (b)(6) 2026 on reagent well 0 and on (b)(6) 2026 on reagent well 1 using different calibration ids.Siemens was unable to determine whether the co2_c calibrator used on (b)(6) 2026 was the same calibrator used on (b)(6) 2026, for which the calibration was acceptable, or whether handling (recapping) of calibrator was performed immediately.Siemens evaluated the event and determined that co2_c calibrations performed by the customer, which recovered atypical calibrator response values, potentially contributed to the erroneously elevated co2_c results.But the cause for the atypical calibrator response values is unknown.A product problem was not identified.The customer is operational.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 6101
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 25081612
• Report Number: 2432235-2026-00099
• Device Sequence Number: 10395623
• Product Code: KHS
• UDI-Device Identifier: 00630414595900
• UDI-Public: (01)00630414595900(10)150329(17)260722
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/05/2026

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: 07/22/2026
• Device Model Number: N/A
• Device Catalogue Number: 11097521
• Device Lot Number: 150329
• 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: 04/12/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2025
• 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