MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP; IMMUNOASSAY 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 01/18/2015

Event Type  malfunction  

Event Description

Discordant vitamin d results were obtained on two patient samples on an advia centaur xp instrument.The initial results were not reported to the physician(s).The samples were repeated on an alternate system.It is unknown which repeat results were reported to the physician(s).There are no known reports of adverse health consequences due to the discordant vitamin d results.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse tested the system wash sequence.The cse determined that the aspirate probe 4 assembly was not adequately drawing liquid from the cuvettes.The cse replaced the aspirate probe 4 assembly and successfully ran quality controls.The cause of the discordant vitamin d results is due to an aspirate probe 4 assembly malfunction.The instrument is performing within specifications.Further evaluation of the device is not required.

• 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 limited; registration number: 8020888; chapel lane, swords co dublin, ; EI
• Manufacturer Contact: john nelson ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 4517903
• MDR Text Key: 5405589
• Report Number: 2432235-2015-00076
• 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: Other
• Type of Report: Initial
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ADVIA CENTAUR XP
• Device Catalogue Number: 078-A010
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/08/2009
• 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