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

Model Number CONCENTRATED CARBON DIOXIDE (CO2_C)

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2020

Event Type  malfunction  

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 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)
• Type of Device: CONCENTRATED CARBON DIOXIDE (CO2_C)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SEKISUI DIAGNOSTICS PEI INC.; 70 watts avenue; registration #: 8020316; charlottetown, pe C1E 2 B9; CA C1E 2B9
• Manufacturer Contact: douglas stanton ; 511 benedict ave.; tarrytown, NY 10591 ; 9145242239
• MDR Report Key: 10871167
• MDR Text Key: 247889148
• Report Number: 2432235-2020-00448
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00630414000541
• UDI-Public: 00630414000541
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1