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

Model Number ADVIA CENTAUR XP

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

A discordant, falsely elevated troponin result was obtained on a redraw sample (sample id: (b)(6)) of one patient on an advia centaur xp instrument.The discordant result was not reported to the physician(s), as a previous sample obtained from the patient (b)(6) was questioned and resulted lower on multiple repeats.The redraw sample was repeated four times on an advia centaur instrument, resulting lower.The corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated troponin result.

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).Quality controls were within range at the time of event.The cause of the discordant, falsely elevated troponin result is unknown.The instrument is performing according to specifications.No further evaluation of the device is 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: cassandra kocsis ; 511 benedict avenue; tarrytown 10591 ; 9145242687
• MDR Report Key: 4405472
• MDR Text Key: 5431628
• Report Number: 2432235-2015-00018
• 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: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• 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-A011-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/28/2008
• 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