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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Patient Data Problem (3197)

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

Event Date 12/24/2014

Event Type  malfunction  

Event Description

The customer contacted the siemens customer care center (ccc) and stated that two patient samples with incorrect patient identification numbers were obtained on a centralink data management system.The patient information in centralink was different from information sent by the laboratory information system.No incorrect patient results were reported to the physician(s) as a result of the event.There are no reports of patient intervention or adverse health consequences due to patient identification numbers being assigned to the incorrect patients.

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).Ccc evaluated the instrument data and discovered incorrect purge settings in centralink.The purge command was set to purge samples with "pending" status.The samples affected in this event were in "scheduled" status, and therefore, were not purged by centralink.Ccc implemented an additional "omit pending samples" command, by remote connection, to include "scheduled", "rerun" and "review" statuses.The cause of incorrect patient identification numbers obtained for two patient samples was an incorrect configuration.The instrument is performing according to specifications.No further evaluation of the device is required.

• 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: cassandra kocsis ; 511 benedict avenue; tarrytown 10591 ; 9145242687
• MDR Report Key: 4423811
• MDR Text Key: 5376808
• Report Number: 2432235-2015-00030
• 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,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• 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
• Date Manufacturer Received: 12/24/2014
• 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