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 Inadequate Storage (1600)

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

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report the discordant carbon dioxide concentrated (co2_c) result.The quality controls (qc) was in range.The initial result was flagged for a rerun.A siemens headquarter support center (hsc) reviewed the information provided and concluded there is not a method or reagent lot issue.The reagent that was used to produce the discordant result was noted as received hot, without ice packs in shipment.The kits were marked as such when put into inventory and used.Service was dispatched but the system was operational and no other assays or performance was in question.A replacement reagent was sent and it was received cool and when put into use has not had any issues.The issue is consistent with reagent integrity compromised during shipping and handling.New shipment of the same reagent lot resolved the issue.The cause of the discordant co2_c result is unknown.The instrument is performing according to the specifications.No further evaluation of this device is required.

Event Description

A discordant, falsely high carbon dioxide concentrated (co2_c) result was obtained on one patient sample on an advia 1800 instrument.The discordant result was not reported to the physician(s).The same sample was repeated on the same instrument, and recovered lower.The repeat result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely high (co2_c) result.

• 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
• Manufacturer (Section G): SEKISUI DIAGNOSTICS PEI INC.; 70 watts avenue; registration#: 8020316; charlottetown, pe C1E 2 B9; CA C1E 2B9
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6722978
• MDR Text Key: 80431810
• Report Number: 2432235-2017-00422
• Device Sequence Number: 1
• Product Code: KHS
• 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: Health Professional
• Type of Report: Initial
• Report Date: 07/18/2017

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 Model Number: ADVIA CHEMISTRY CARBON DIOXIDE REAGENT, CONCENTRATED (CO2_C)
• Device Lot Number: LOT # 4990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2017
• Initial Date FDA Received: 07/18/2017
• 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: Reuse
• Patient Sequence Number: 1