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 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was sent to the customer's site for instrument inspection.Controls were tested in 10 replicates to check precision, and did not indicate a precision issue.There were no issues observed in the event log.The cse replaced the degasser, capsule filter, aspiration guide, pinch tubing, and adjusted the incubation ring and probes.The cse checked the b/f line, and fluid lines, and decontamination performed.The customer uses terumo blood (9 ml) collection tubes, and does not know how long the sample was allowed to clot before centrifugation.The terumo blood collection tube has a clot activator but does not have gel separator.The sample was centrifuged at 3,500 revolutions per minute (rpm) for 10 minutes.The cause for the discordant afp result is unknown.The non-reproduced elevated afp result may be attributed to insufficient clotting time and/or centrifugation.Siemens has recommended the customer allow samples to clot for at least 30 minutes before centrifugation, and centrifuge samples at 1000 x gravitational force (g) for 15-20 minutes.The instruction for use (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 instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." the instrument is performing within specification.No further evaluation of the device is required.

Event Description

A falsely elevated advia centaur xpt alpha-fetoprotein (afp) result was observed on a patient sample.The patient sample was repeated on two other advia centaur systems and the results were lower.The lower result was reported to the provider.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant advia centaur xpt result.

• 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; east walpole MA 02032
• Manufacturer Contact: stephen perry ; 333 coney street; east walpole, MA 02032 ; 5086604163
• MDR Report Key: 6607831
• MDR Text Key: 76519148
• Report Number: 1219913-2017-00138
• 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: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2017
• Device Model Number: N/A
• Device Catalogue Number: 10309979
• Device Lot Number: 041182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1