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

Model Number	CONCENTRATED CARBON DIOXIDE (CO2_C)
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) about multiple discordant, falsely elevated concentrated carbon dioxide (co2_c) patient results on an advia 1800 instrument.The customer replaced the reagent and ran calibration and quality controls, which recovered acceptably.Maintenance was up to date and there were no errors in the event log.The customer declined service.A reagent contamination potentially contributed to the discordant, falsely elevated co2_c results.The device is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
Multiple discordant, falsely elevated concentrated carbon dioxide (co2_c) patient results were obtained on an advia chemistry 1800 instrument using reagent lot 090.The initial results were reported to a physician(s).The samples were repeated on an alternate advia chemistry 1800 instrument and the repeat results were lower than the initial results.The repeat results were reported to the physician(s) as corrected results.The customer provided two examples of discordant results.There are no known reports of patient intervention or adverse health consequences due to the discordant co2_c results.

• Brand Name: CONCENTRATED CARBON DIOXIDE (CO2_C)
• Common Device Name: CONCENTRATED CARBON DIOXIDE (CO2_C)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 10871167
• Report Number: 2432235-2020-00448
• Device Sequence Number: 3254203
• Product Code: KHS
• UDI-Device Identifier: 00630414000541
• UDI-Public: 00630414000541
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2020

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: 09/30/2021
• Device Model Number: CONCENTRATED CARBON DIOXIDE (CO2_C)
• Device Catalogue Number: 10720780
• Device Lot Number: 090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1