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

Model Number ADVIA CHEMISTRY CARBON DIOXIDE REAGENT, CONCENTRATED (CO2_C)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center.Quality controls (qc) on the morning of event occurrence were acceptable.The customer noticed that the patient samples were elevated.The customer ran qc and found that the results were out of range high.The customer performed assay calibration, which failed.The reagent blank tracking was also failing.The customer ran qc for other assays, which were acceptable.The customer installed a new reagent wedge of the same kit lot and ran calibration and qc, which were acceptable.The issue was resolved with the replacement of reagent wedge.The device is performing within manufacturing specifications.No further evaluation of device is required.

Event Description

Discordant, falsely elevated carbon dioxide, concentrated (co2_c) results were obtained on multiple patient samples on an advia 1800 instrument, while using reagent lot 010.The initial results for ten patient samples were reported to the physician(s).The discordant results for the rest of the patient samples were not reported to the physician(s).After replacing the reagent wedge, the samples were repeated on the same instrument, resulting lower.The corrected results for five of ten patient samples were reported to the physician(s), as the discordant results for those samples were initially reported.It is unknown if the other five samples repeated same.The repeat results were reported for the rest of the samples.There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated co2_c results.

Event Description

Discordant, falsely elevated carbon dioxide, concentrated (co2_c) results were obtained on ten patient samples on an advia 1800 instrument, while using reagent lot 010.The initial results were reported to the physician(s).After replacing the reagent wedge, the samples were repeated on the same instrument, resulting lower.The corrected results for five of ten patient samples were reported to the physician(s), as the discordant results for those samples were initially reported.It is unknown if the other five samples repeated same and if the repeat results were reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated co2_c results.

Manufacturer Narrative

The initial mdr 2432235-2018-00302 was filed on 20-jul-2018.Corrected information (23-jul-2018): based on the clarification received, only ten patient samples were affected.Describe event or problem has been updated to reflect the correct information.

• Brand Name: ADVIA CHEMISTRY CARBON DIOXIDE REAGENT, CONCENTRATED (CO2_C)
• Type of Device: ADVIA CHEMISTRY CARBON DIOXIDE REAGENT, CONCENTRATED (CO2_C)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 7705894
• MDR Text Key: 114547047
• Report Number: 2432235-2018-00302
• Device Sequence Number: 1
• Product Code: KHS
• UDI-Device Identifier: 00630414553177
• UDI-Public: 00630414553177
• Combination Product (y/n): N
• PMA/PMN Number: K100289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/24/2018

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: 04/30/2019
• Device Model Number: ADVIA CHEMISTRY CARBON DIOXIDE REAGENT, CONCENTRATED (CO2_C)
• Device Catalogue Number: 10283345
• Device Lot Number: 010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 07/20/2018
• Supplement Dates Manufacturer Received: 07/23/2018
• Supplement Dates FDA Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1