MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2400

Model Number ADVIA 2400

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

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

Event Date 12/30/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The cse carried out coefficient of variation check, which was acceptable.The cause of the discordant crea_2c results on patient samples is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant concentrated creatinine (crea_2c) results were obtained on an advia 2400 instrument.The discordant results were reported to the physician(s), who questioned them.New samples were obtained from the patients and were tested on an alternate advia 2400 instrument, resulting different and matching the clinical picture of the patients.The corrected results obtained on the alternate advia 2400 instrument were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant crea_2c results.

Manufacturer Narrative

The initial mdr 2432235-2017-00070 was filed on january 19, 2017.Additional information (02/16/2017): siemens had sent a different reagent lot to the customer to perform comparison.The customer did not obtain additional discordant results since they have been using the new reagent lot.The cause of the discordant crea_2c results on patient samples is unknown.

• Brand Name: ADVIA 2400
• Type of Device: ADVIA 2400
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; registration #: 3003637681; 3-1-2 musashino akishim; tokyo 96-85 58; JA 96-8558
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6264642
• MDR Text Key: 65307433
• Report Number: 2432235-2017-00070
• Device Sequence Number: 0
• Product Code: CGX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K990346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA 2400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2016
• Initial Date FDA Received: 01/19/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/22/2014
• 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