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

Model Number ADVIA CENTAUR XP

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

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

Event Date 08/04/2014

Event Type  malfunction  

Event Description

The operator of an advia centaur xp instrument stated that a diluter 3 error was produced by the instrument.Quality controls (qc) were run and were out of range.The operator calibrated the instrument and then ran qc, which was then within range.Patient samples were run on the instrument once qc was within range.When qc was run again later that day, it was out of range.The patient samples were repeated on an unknown instrument and the customer stated that four results required corrected reports.It is unknown if what methods the corrected reports were for or if the initial results had been reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant results.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument, the cse discovered that the cuvette ring was not able to operate properly due to a missing dispense port in the cuvette wash manifold.The cse replaced the wash manifold and verified that the instrument was operational.The cause of the discordant results was a malfunction of the cuvette wash manifold.This instrument is performing according to specifications.No further evaluation of this device is required.

Manufacturer Narrative

The initial mdr 2432235-2014-00507 was filed on august 29, 2014.Additional information (08/22/2014): the test results were provided by the customer.

Event Description

Discordant results were obtained on patient samples tested for vitamin d, thyroid stimulating hormone (tsh), and free thyroxine (ft4).

• 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: 4048034
• MDR Text Key: 4865152
• Report Number: 2432235-2014-00507
• 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,Followup
• Report Date: 08/22/2014

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: 08/22/2014
• Initial Date FDA Received: 08/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1