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

Model Number ADVIA CENTAUR

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/30/2014

Event Type  malfunction  

Event Description

Four patient samples were delayed from testing for troponin on an advia centaur instrument.The test orders for the samples were ordered through the versacell sample management system.The operator discovered that the troponin tests had not been processed on the advia centaur instrument and attempted to front-load the samples directly on the instrument, but the samples would not run.The operator then ran the samples on an alternate instrument.There was a delay of up to two hours processing the samples.There are no known reports of patient intervention or adverse health consequences due to the delay in processing samples for troponin.

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).During troubleshooting, it was discovered that the versacell sample management system had posted erroneous inventory errors for the troponin method on the advia centaur instrument, which prevented the troponin tests from being processed.The ccc specialist instructed the customer to remove any empty troponin packs that were on the system as well as other reagent packs for troponin.The customer was then advised to close the reagent compartment door so that an updated inventory was sent to the versacell, then place adequate reagent packs back onto the advia centaur instrument.A siemens customer service engineer (cse) was dispatched to the customer site to update the software on the advia centaur instrument from 7.1.1.2 sp1 to 7.1.1.2 sp2.There were no further false inventory errors produced by the versacell after the software update was performed.The cause of the delay in processing troponin samples was a software problem on the advia centaur.This instrument is performing according to specifications.No further evaluation of the 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: 4353975
• MDR Text Key: 5197703
• Report Number: 2432235-2014-00733
• Device Sequence Number: 1
• Product Code: MMI
• 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: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• 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: 12/01/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/22/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1