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 02/27/2015

Event Type  malfunction  

Event Description

Discordant, falsely elevated carcinoembryonic antigen (cea) results were obtained on two patient samples on an advia centaur xp instrument.The discordant results were reported to the physician(s), who questioned them.The samples were repeated on the same instrument four times for patient (b)(6) and twice for patient (b)(6), all resulting lower than the initial results, except the first repeat run for the patient (b)(6) which was also elevated compared to the normal range.The corrected results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated cea results.

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.The cse evaluated the instrument and did not find any instrument malfunction.The cse proactively replaced the pinch valve.The cause of the discordant, falsely elevated cea results on two patient samples 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 ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, co., dublin ; EI
• Manufacturer Contact: michael metz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242223
• MDR Report Key: 4625803
• MDR Text Key: 5658143
• Report Number: 2432235-2015-00137
• Device Sequence Number: 1
• Product Code: LTK
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2015
• 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: 110761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2009
• 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