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

Catalog Number	11097521
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously elevated carbon dioxide, concentrated (co2_c) result obtained on a patient sample on an atellica ch 930 analyzer.Siemens is evaluating the event.
Event or Problem Description
The customer reported to siemens that they obtained an erroneously elevated carbon dioxide, concentrated (co2_c) result on a patient sample on an atellica ch 930 analyzer.The erroneous result was reported to the physician, and it is unknown whether the result was questioned.The same sample was reprocessed on an alternate advia 1800 instrument.The lower reprocessed result obtained was considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated carbon dioxide, concentrated (co2_c) result.
Additional Manufacturer Narrative
Initial mdr 2432235-2025-00280 was filed on 24-oct-2025.Additional information (16-dec-2025): siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the available instrument data files and the information provided by the customer, and found that quality control (qc) was not recovered within the ranges.A new carbon dioxide, concentrated (co2_c) reagent pack was loaded and calibrated, and quality control (qc) recovery was acceptable.Also, the review of the instrument data suggested that the reagent well was contaminated.The cause of the event is unknown.A product issue was not identified.The device is performing within specifications.No further evaluation is required.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated to reflect the additional information.

• 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.; registration # 2517506; 500 gbc drive, po box 6101; 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: 23380607
• Report Number: 2432235-2025-00280
• Device Sequence Number: 9091321
• Product Code: KHS
• UDI-Device Identifier: 00630414595900
• UDI-Public: (01)00630414595900(10)150174(17)260414
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 01/09/2026

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 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: 10/02/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 01/09/2026
• 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 Age: 14 YR
• Patient Sex: Female