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

Model Number ADVIA CENTAUR XP

Device Problem False Device Output (1226)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2013

Event Type  malfunction  

Event Description

The customer reported false external qc (probioqual) on troponin i on an advia centaur xp instrument.There were no discordant results associated with this event.The external qc (probioqual) on troponin i was repeated on an alternate system and was determined to be the correct result.There were no reports of adverse health consequences or known patient intervention due to the invalid qc (probioqual) on troponin i.

Manufacturer Narrative

A siemens field service engineer (fse) was dispatched to the customer site to evaluate the instrument and instrument data.The fse determined that the cause of the discordant false external qc (probioqual) on troponin i result was unknown.The fse proactively replaced the wash station and aspiration probe and ran qc.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; registration number: 8020888; manufacturing limited; chapel lane, swords co dublin, ; EI
• Manufacturer Contact: john nelson ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 3595917
• MDR Text Key: 4190087
• Report Number: 2432235-2014-00151
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K041133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• 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-A010-02
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 YR
• Date Manufacturer Received: 01/03/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2010
• 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