MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK DATA MANAGEMENT SYSTEM; DATA MANAGER

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

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

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

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer's site.The cse evaluated the instrument.The cse found that the other instrument translators start without any issues.The laboratory information system (lis) translator, is not starting in the centralink dashboard but is starting in the windows services console.The cse agreed to the regional service center (rsc) to remotely dial in.Rsc ran a command on the centralink server and found the specific port, that the lis translator was connected to, was being used by another internal function.The cse changed the transmission control protocol/internet protocol (tcp/ip) port, which allowed for the lis translator to properly start up.The cause of the delay was due to an incorrect tcp/ip port being used due to the user.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Customer reported they are unable to start their laboratory information system translator from their centralink data management system, causing a delay to samples.There are no reports of patient intervention or adverse health consequences due to the delay.

• Brand Name: CENTRALINK DATA MANAGEMENT SYSTEM
• Type of Device: DATA MANAGER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICSMANUFACTURING LTD; registration #: 8020888; chapel lane; swords, co, dublin 10040 ; EI 10040
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6179554
• MDR Text Key: 62540742
• Report Number: 2432235-2016-00771
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CENTRALINK DATA MANAGEMENT SYSTEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: No
• 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