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

Model Number ADVIA CENTAUR XP

Device Problem Patient Data Problem (3197)

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

Event Date 05/02/2014

Event Type  malfunction  

Event Description

The operator of an advia centaur xp instrument discovered that one patient's sample identification (sid) number was incorrectly matched with the name of a different patient whose sample had been tested a few days prior.The other patient's sid had been correctly matched with their name.The issue was identified prior to 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

In an investigation conducted by siemens healthcare diagnostics, it was discovered that under specific scenarios, patient demographics from one sample id can be mismatched and applied to the subsequent patient sample id.The name and patient id of the previous sample are incorrectly transmitted to the lis with the results of the current patient sample.The results being transmitted to the laboratory information system are still correctly identified by sample id, which is used as a unique identifier.The cause of one patient's sample id being incorrectly matched with the name of a different patient is a software problem.Siemens is investigating this issue.

Manufacturer Narrative

The initial mdr 2432235-2014-00347 was filed on may 27, 2014.The first supplemental mdr 2432235-2014-00347_s1 was filed on august 19, 2014.Additional information (08/20/2014): the correction/removal report was filed with the fda on august 20, 2014.

Manufacturer Narrative

The initial mdr 2432235-2014-00347 was filed on may 27, 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.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, co., dublin ; EI
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 3833799
• MDR Text Key: 4499292
• Report Number: 2432235-2014-00347
• Device Sequence Number: 1
• Product Code: MOI
• 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,Followup
• Report Date: 05/02/2014

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 CENTAUR XP
• Device Catalogue Number: 078-A010-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2014
• Initial Date FDA Received: 05/27/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/19/2014; 09/03/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2007
• Is the Device Single Use?: 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