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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Computer Software Problem (1112)

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

Event Date 08/08/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens headquarter support center (hsc) specialist evaluated the instrument data.When the work-order for the sample in question was downloaded to the automation system it did not have the correct sample type (came in as "default"), and therefore the centrifuge pre-test was not assigned by the automation system to this sample.The automation system performed as expected.A siemens service personnel was dispatched to the customer site, and modified the laboratory automation system (las) dispatch command so that only samples older than 30 seconds will dispatch to the las.Siemens healthcare diagnostics has determined that there is a remote possibility centralink may download an order to the advia automation system without specifying the sample type.This can occur when an order is received from the laboratory information system (lis) without a sample type, requiring that the sample type be set in centralink based on the sample type of the test in the order.Urgent medical device correction (umdc) isw-17-01.A.Us was sent to customers in the united states in november 2016 and corresponding urgent field safety notice (ufsn # isw-17-01.A.Ous) to all outside us centralink® data management system customers.The umdc and ufsn are entitled "sample type may not download to advia® labcell or advia® workcell automation systems." the umdc and ufsn explain that if the automated task to download samples to the laboratory automation system (las) processes immediately after the order is received from the lis, there is a possibility that a test may be downloaded before the sample type on the sample record is set.On advia automation, the value "default" will be downloaded instead of the sample type value.This issue may affect advia automation systems that have activities based on sample type.Siemens recommends the lis specify the sample type in the work order.

Event Description

An unspun chemistry patient sample was routed to an advia 1800 instrument for analysis prior to being routed to the centrifuge.Discordant results were obtained but were not reported to the physician(s).The sample was spun and retested, and corrected results were obtained.The corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant results.

• Brand Name: CENTRALINK DATA MANAGEMENT SYSTEM
• Type of Device: DATA MANAGER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, co., dublin ; EI
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown 10591 ; 9145243105
• MDR Report Key: 6191475
• MDR Text Key: 62918306
• Report Number: 2432235-2016-00740
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/28/2016

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: 11/28/2016
• Initial Date FDA Received: 12/20/2016
• 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
• Removal/Correction Number: 2432235-12/09/2016-011-C
• Patient Sequence Number: 1