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

Model Number ADVIA CENTAUR XP

Device Problem High Test Results (2457)

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

Event Date 11/27/2014

Event Type  malfunction  

Event Description

A discordant, falsely elevated troponin result was obtained on one aliquot from one patient sample on an advia centaur xp instrument.Four aliquots from the sample were tested on the instrument and the third was falsely elevated.All results were reported to the physician(s) and the discordant result was questioned.The third and fourth aliquots were repeated on an alternate advia centaur instrument and then on the original advia centaur xp.The third aliquot resulted lower and matched the other results and the fourth aliquot repeated the same.It is unknown if the corrected result for the third aliquot was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant troponin result.

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The customer stated that the sample appeared slightly hemolyzed.A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument, the cse performed a total service call.The cse checked dispense and aspiration function, verified that the acid and base pumps were working, and checked dark counts.Background tests were run and passed.Quality controls were run to verify that the instrument was operational.The cause of the discordant troponin result on one aliquot from a patient sample is unknown.This instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; 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: 4340526
• MDR Text Key: 5180627
• Report Number: 2432235-2014-00727
• 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
• Type of Report: Initial
• Report Date: 11/27/2014

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-A011-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1