MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP; IMMUNOASSAY ANALYZER

Model Number ADVIA CENTAUR XP

Device Problems Incorrect Or Inadequate Test Results (2456); Device Operates Differently Than Expected (2913)

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

Event Date 01/03/2014

Event Type  malfunction  

Event Description

The operator of an advia centaur xp instrument ran multiple patient samples being tested for (b)(6).Upon review of results after the run, the operator discovered that one patient's sample identification (sid) number was incorrectly matched with the name of a different patient whose sample had also been tested in the run.The other patient's sid had been correctly matched with their name.The issue was identified prior to incorrect results being reported to the physician(s) for one patient.There are no known reports of patient intervention or adverse health consequences due to one patient's sid being incorrectly matched with the name of a different patient.

Manufacturer Narrative

A siemens global product support (gps) specialist reviewed the instrument data and did not find an instrument malfunction.The customer stated that their laboratory information system (lis), which is not a siemens product, had produced an error for an unknown record type during the run.The cause of one patient's sid being incorrectly matched with the name of a different patient is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

Manufacturer Narrative

The initial mdr 2432235-2014-00156 was filed on january 31, 2014.Additional information (08/12/2014): siemens healthcare diagnostics has identified an issue with patient demographic information sent to the lis from the advia centaur/advia centaur xp immunoassay systems.Siemens has confirmed that under extremely rare circumstances patient demographic data from the previous order received from the lis is merged with the next order.This issue can occur when the lis data buffer on the advia centaur system becomes full and a particular character is found in the last five locations in the lis data buffer.In this case, the incorrect patient demographic information will be transmitted to the lis and will be displayed on the advia centaur user interface and instrument generated printed reports.Urgent medical device correction (umdc) 10819176 entitled "advia centaur/advia centaur xp incorrect patient demographic information" was sent to customers in the united states and urgent field safety notice (ufsn) 10819175 entitled "advia centaur/advia centaur xp incorrect patient demographic information" was sent to customers outside the united states in august 2014.The umdc and ufsn describe the issue and provide actions for customers to take if their instrument is interfaced to an lis system that transmits patient demographics with each order.Corrected information: the product code in the initial mdr was listed as jje.The correct product code is moi.The 510(k) number in the initial mdr was listed as k041133.The correct 510(k) number is k971418.This information has been changed, respectively.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.; chapel lane; registration number: 8020888; dublin, swords ; EI
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 3602640
• MDR Text Key: 4190257
• Report Number: 2432235-2014-00156
• Device Sequence Number: 1
• Product Code: NHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ADVIA CENTAUR XP
• Device Catalogue Number: 078-A011-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2432235-08/20/14-006-C
• Patient Sequence Number: 1