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

Model Number ADVIA CENTAUR

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2015

Event Type  malfunction  

Event Description

Discordant results were obtained on patient samples tested for multiple methods on an advia centaur instrument.It is unknown if discordant results were reported to the physician(s).It is unknown if repeat testing was performed and if corrected reports were sent out.There are no 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.Prior to cse arrival, the customer tried to perform the monthly maintenance procedure, which failed.After evaluation of the instrument and instrument data, the cse found clumpy reagents and a centaur water bottle next to the system that was filled with contaminated fluid.The cse asked the customer not to use the system water bottles for waste or any other fluids except deionized water or cleaning solution and to use their reagent grade deionized water containers to fill the system water bottle until the quality of their deionized tap water could be verified.The cse also discovered that the refrigerator that is being used to store the centaur reagents is in a hallway next to a cold garage, and the refrigerator's temperature is not being monitored for the daily minimum and maximum temperatures.The cse discussed the issue with the customer and two digital thermometers were installed in the refrigerator.The cse performed the monthly cleaning procedure, without issues.The customer ran quality controls.The cause of the discordant results is unknown.The 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 limited; registration number: 8020888; chapel lane, swords, co., dublin ; EI
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown 10591 ; 9145242687
• MDR Report Key: 4618148
• MDR Text Key: 5762828
• Report Number: 2432235-2015-00134
• 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: 02/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• 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-A001-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1