MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH; ATELLICA CH CONCENTRATED CARBON DIOXIDE (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	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that falsely elevated concentrated carbon dioxide (co2_c) results were obtained on 10 patient samples on an atellica ch 930 analyzer.Quality control (qc) and calibration were acceptable on the day of the event.The customer performed the calibration.Siemens remotely reviewed the instrument data and observed that reagent arm 1 marked a reagent pack well as unusable because of 3 consecutive reagent aspiration errors, well 1 of the co2 pack was disabled.Further, siemens remotely inspected reagent probe 1 (rp1), and reagent pack and performed an auto check on rp1.Siemens is evaluating the event.
Event or Problem Description
The customer reported that falsely elevated concentrated carbon dioxide (co2_c) results were obtained on 10 patient samples on an atellica ch 930 analyzer.The initial results were reported to the physician(s).The samples were repeated on an alternate atellica ch 930 analyzer.The repeat results recovered lower than the initial results and matched the patient's history.The repeat 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 falsely elevated co2_c results.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2025-00004 on 03-jan-2025.Additional information (02-apr-2025): siemens further evaluated the event and concluded that an atypical lot calibration potentially contributed to the falsely elevated concentrated carbon dioxide (co2_c) results.A new calibration was performed by the customer on the same reagent well which resolved the issue.Sections d1, d2, d4, g1, g4, h4, and h8 were updated to reflect the additional/corrected information.The component code, type of investigation code, investigation findings code, and investigation conclusions code were updated to reflect the additional information.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ATELLICA CH
• Common Device Name: ATELLICA CH CONCENTRATED CARBON DIOXIDE (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: 21065469
• Report Number: 2432235-2025-00004
• Device Sequence Number: 19685533
• Product Code: KHS
• UDI-Device Identifier: 00630414595900
• UDI-Public: (01)00630414595900(10)140215(17)250617
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/24/2025

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: 06/17/2025
• Device Model Number: N/A
• Device Catalogue Number: SMN 11097521
• Device Lot Number: 140215
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2024
• 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