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

Model Number	CARBON DIOXIDE REAGENT, CONCENTRATED (CO2_C)
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center and reported that falsely depressed concentrated carbon dioxide (co2_c) results were obtained on samples from the same patient on an advia chemistry xpt instrument.The customer requested samples from the patient for further investigation.The samples are being tested for interference substances.Additionally, the methodology differences may contribute to the differences in results.Siemens is investigating the issue.
Event or Problem Description
The customer reported that beginning in (b)(6) 2020, discordant, falsely depressed concentrated carbon dioxide (co2_c) results were obtained on samples from the same patient on an advia chemistry xpt instrument using reagent lot 070.Samples are being drawn from this in-patient every day and the samples recovered at 10-12 mmol/l for co2_c daily.On (b)(6) 2020, a physician questioned the results and a sample from the patient was repeated on an alternate non-siemens instrument and an alternate blood gas analyzer.The results obtained on the alternate instruments recovered higher and the patient's clinical picture gave the customer confidence that the result from the blood gas analyzer was correct.There are no known reports of patient intervention or adverse health consequences due to the falsely depressed co2_c results.
Additional Manufacturer Narrative
Siemens filed initial mdr 2432235-2020-00348 on 20-jul-2020.Additional information (25-aug-2020): siemens tested the affected patient sample on three siemens platforms (advia chemistry xpt, dimension vista 500 and dimension exl) to determine a potential interference issue.The sample was tested for carbon dioxide (co2), immunoglobulin a, immunoglobulin m, and immunoglobulin g on the advia chemistry xpt instrument and for co2 on the dimension exl and dimension vista 500 instruments.The patient sample was also tested for lambda and kappa.Siemens' investigation does not suggest paraprotein interference as a probable cause of the low co2 results.Examination of the list of medications prescribed to the patient does not suggest a potential interferant with the co2_c assay.The probable cause of the low co2 results for multiple samples from this specific patient is unknown.The result code and conclusion code were updated to reflect the additional information.The device is performing according to specifications.No further evaluation of this device is required.

• Brand Name: CARBON DIOXIDE REAGENT, CONCENTRATED (CO2_C)
• Common Device Name: CARBON DIOXIDE REAGENT, CONCENTRATED (CO2_C)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown, ny
• MDR Report Key: 10299473
• Report Number: 2432235-2020-00348
• Device Sequence Number: 2496464
• Product Code: KHS
• UDI-Device Identifier: 00630414553177
• UDI-Public: 00630414553177
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 09/23/2020

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: 07/31/2021
• Device Model Number: CARBON DIOXIDE REAGENT, CONCENTRATED (CO2_C)
• Device Catalogue Number: 10283345
• Device Lot Number: 070
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1