MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT AFP ASSAY; KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS

Model Number N/A

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

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

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

No issues were identified for the advia centaur xpt unit 1 by the siemens field service engineer (fse).No problems were found in the event log at the time of the event.A secondary tube was used for the run on the advia centaur xpt unit 1.The sample was centrifuged at 3000 rpm for 5 minutes.The same secondary tube was used for the run on unit 3.The sample was not centrifuged prior to running on unit 3.A new secondary tube was used for the run on unit 12.The sample was not centrifuged prior to running on unit 12.The instructions for use (ifu) recommends centrifuging samples at 1000 x gravitational force (g) for 15-20 minutes to remove particulates.It is possible that some sort of particulate matter in the sample caused the initial elevated result.The cause for the discordant afp results is unknown.It is possible that insufficient centrifugation may have caused the initial elevated result.The instrument is performing within specification.No further evaluation of the device is required.The ifu states in the preparing the samples section: "before placing samples on the system, ensure that samples have the following characteristics: samples are free of fibrin or other particulate matter.Remove particulates by centrifugation at 1000 x g for 15-20 minutes.Samples are free of bubbles." the ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings.".

Event Description

A falsely elevated advia centaur xpt afp result was obtained for a patient sample.The patient sample was repeated on two other advia centaur xpt instruments.Both results were lower.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant afp results.

• Brand Name: ADVIA CENTAUR XPT AFP ASSAY
• Type of Device: KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 6237012
• MDR Text Key: 64343789
• Report Number: 1219913-2016-00283
• Device Sequence Number: 1
• Product Code: LOK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P930036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 03974780
• Device Lot Number: 041181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1