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 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched at the customer's site.The cse evaluated the instrument and performed a total service visit, and found no issue.The cse ensured that alignments and dispenses were operating correctly.The customer ran quality controls, resulting satisfactory.The cause of the discordant, falsely elevated thcg results is unknown.The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

On (b)(6) 2017, the customer informed siemens that discordant, falsely elevated total human chorionic gonadotropin (thcg) results were obtained on two patient samples on an advia centaur xp instrument.The discordant results on sample (b)(6) were obtained (b)(6) 2017 and the discordant result on the other patient sample had occurred the previous week and the customer did not have the date or sample id number.The discordant results were reported to the physician(s) who questioned them.Sample (b)(6) was repeated on the same instrument, resulting lower than the initial result but still falsely elevated.A different tube of the same draw on the same patient was tested on the same instrument, resulting lower and as expected.A corrected result was reported to the physician(s).The sample from the unknown patient had been repeated on the same instrument, resulting lower.A 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 hcg 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 INC.; manufacturing limited; registration number: 8020888; chapel lane, swords, co. dublkin ; EI
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6380635
• MDR Text Key: 69214263
• Report Number: 2432235-2017-00114
• Device Sequence Number: 0
• Product Code: DHA
• 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: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2010
• 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