MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY CARBON DIOXIDE REAGENT, CONCENTRATED; ENZYMATIC, 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	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens they obtained erroneously elevated carbon dioxide concentrated (co2_c) results on three (3) patient samples on an advia chemistry xpt system.The erroneously elevated results were not reported to the physician(s).The same samples were reprocessed on an alternate advia chemistry xpt system.Lower results were obtained, considered correct, and not reported 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
An outside united states (ous) customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding three (3) erroneously elevated carbon dioxide concentrated (co2_c) patient sample results obtained on an advia chemistry xpt system.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (28-aug-2025): siemens healthcare diagnostics service operations support (sos) concluded the investigation of the event.Sos reviewed the information provided by the customer.No reagent issues were identified.A siemens customer service engineer (cse) was dispatched to the customer's site and inspected the instrument.The cse performed a variety of troubleshooting steps on the instrument and observed inadequate aspiration.The cse replaced the aspiration pump tubing of the instrument, which is considered routine service.The customer stated the issue was resolved and no other discordant results were reported.The customer is operational.The device is performing within specifications.A potential product issue was not identified.No further evaluation is required.Section h6 has been updated to reflect the sos investigation.Initial mdr 2432235-2025-00221 was filed on 26-aug-2025.

• Brand Name: ADVIA CHEMISTRY CARBON DIOXIDE REAGENT, CONCENTRATED
• Common Device Name: ENZYMATIC, CARBON-DIOXIDE
• 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: isaac dashefsky ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 22893297
• Report Number: 2432235-2025-00221
• Device Sequence Number: 8984710
• Product Code: KHS
• UDI-Device Identifier: 00630414553177
• UDI-Public: (01)00630414553177(10)170(17)260131
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/02/2025

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: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 10283345
• Device Lot Number: 170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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