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

Model Number ADVIA CENTAUR XP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist and stated that their (b)(6) total quality controls (qc) were out of range.The customer stated that the failed qc samples did not flag and therefore they reported the patient results without verifying them.The customer discovered the failed qc later.A siemens customer service engineer (cse) specialist was dispatched to the customer site.The cse performed a total service check and did not find any malfunctions.The failed qc results were recorded by the advia qc application and flagged appropriately.A flashing error message will not display on the user interface for a non-numeric assay qc failure.This is an expected behavior of the advia centaur xp instrument.A siemens technical applications specialist explained the behavior of the advia centaur xp instrument to the customer.The cause of the (b)(6) total qc being out of range is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, (b)(6) results were obtained on three patient samples on an advia centaur xp instrument.The discordant results were reported to the physician(s).The samples were repeated on the same instrument, resulting (b)(6).The corrected (b)(6) results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, (b)(6) total results.

• 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: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6076261
• MDR Text Key: 59063348
• Report Number: 2432235-2016-00653
• Device Sequence Number: 0
• Product Code: LOL
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2010
• 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