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

Model Number ADVIA CENTAUR

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2014

Event Type  malfunction  

Event Description

A discordant, falsely elevated troponin result was obtained on one patient sample on an advia centaur instrument.The discordant result was reported to the physician(s), who transferred the patient to the cardiac catheterization unit (ccu).The patient was assessed and the erroneous result was discovered before patient intervention.The sample was repeated on an unknown instrument twice and resulted lower.The corrected result was not reported to the physician(s), as it had been determined that the result was erroneous during the patient assessment in the ccu.There are no known reports of patient intervention or adverse health consequences due to the discordant troponin result.

Manufacturer Narrative

A siemens customer service engineer (cse) and a siemens technical application specialist (tas) were dispatched to the customer site.After evaluation of the instrument, the tas decontaminated the acid, base, wash 1 solution, and water lines.The tas then ran multiple replicates of multi-diluent, negative quality control (qc) material, and a patient pool and discovered that qc precision was out of specification and two patient values were incorrect.The cse replaced the wash manifold and then the tas repeated qc and the patient pool, obtaining an acceptable coefficient of variation (%cv).The cause of the discordant, falsely elevated troponin result was related to a malfunction of the wash manifold.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CENTAUR
• 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: 4462421
• MDR Text Key: 17935274
• Report Number: 2432235-2015-00050
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR
• Device Catalogue Number: 078-A002-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/25/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1