MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CHEMISTRY XPT CARBON DIOXIDE CONCENTRATED (CO2_C); ENZYMATIC, CARBON-DIOXIDE

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc) to report a falsely depressed advia chemistry xpt concentrated carbon dioxide (co2_c) result that was obtained on one patient sample.The result was not reported to the physician(s).The sample was retested on an alternate advia chemistry xpt instrument.The retest result was higher and was reported as the correct result to the physician(s).This same sample also resulted a <0 on saline used for checking hil and alt "error".It is unknown if the saline was replaced.The customer has not reported any additional discordant co2_c results for any other patient samples and there were no problems with quality control, suggesting the issue is sample specific and isolated to the initial run of sample id (b)(6).No other information was provided by the customer.The interpretation of results section of the instructions for use (ifu) states, "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.".The limitations section of the ifu states, "as with any chemical reaction, you must be alert to the possible effect on results of unknown interferences from medications or endogenous substances.The laboratory and physician must evaluate all patient results in light of the total clinical status of the patient.".The cause of the disccordant low co2_c result is inconclusive based on the information provided.This was an isolated event, likely sample specific.Siemens has reviewed the information provided and concluded that it is not a reagent lot or method issue.There is no evidence of a potential product issue.The instrument is fully operational.No further evaluation of this device is required.
Event or Problem Description
A falsely depressed carbon dioxide concentrated (co2_c) result was obtained on a patient sample on an advia chemistry xpt instrument, s/n: (b)(6).The erroneous result was not reported to the physician(s).The sample was repeated on an alternate advia chemistry xpt instrument, s/n: (b)(6).The repeat result was higher than the initial erroneous result.The repeat result was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant co2_c result.

• Brand Name: ADVIA CHEMISTRY XPT CARBON DIOXIDE CONCENTRATED (CO2_C)
• Common Device Name: ENZYMATIC, CARBON-DIOXIDE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SEKISUI DIAGNOSTICS PEI INC.; 70 watts avenue; registration # 8020316; charlottetown, pe C1E 2 B9; CA C1E 2B9
• Manufacturer Contact: stacy loukos ; 333 coney st.; registration #: 1219913; east walpole, MA 02032
• MDR Report Key: 16834837
• Report Number: 1219913-2023-00122
• Device Sequence Number: 6823759
• Product Code: KHS
• UDI-Device Identifier: 00630414553177
• UDI-Public: 00630414553177
• Combination Product (Y/N): N
• Initial Reporter Country: BA
• PMA/510(K) Number: K100289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• 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): 04/28/2023

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: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 10283345
• Device Lot Number: 120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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: 40 YR
• Patient Sex: Male