MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP; CLINICAL CHEMISTRY ANALYZER

Model Number ADVIA CENTAUR XP

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2014

Event Type  malfunction  

Event Description

The operator of an advia centaur xp instrument stated that a physician questioned patient results and requested that the operator perform a review.The samples were repeated several times on another centaur instrument, and corrected results were obtained.The corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant results.

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The customer stated to ccc that quality controls (qc) were run, resulting out of range.The customer then repeated all samples which were run on the instrument since qc were last within range, on an alternate instrument, and corrected results were obtained.A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse discovered a crack on aspirate probe 1, and replaced it.The cause of the discordant results was a crack in aspirate probe 1.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: CLINICAL CHEMISTRY 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: 4348629
• MDR Text Key: 5141163
• Report Number: 2432235-2014-00730
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/29/2014

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-A010-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2012
• 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