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 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

The customer runs esoteric testing on an advia centaur xp instrument (cxp1) and (b)(6) testing on another advia centaur xp instrument (cxp2).After the incident occurred the ccc disabled in centralink, (b)(6) testing on the cxp1 instrument, to stop the test from downloading to that instrument.The customer ran a test patient, and testing was performing as expected.The cause of the (b)(6) results reported out was due to a user error.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The customer contacted the siemens customer care center (ccc).The customer stated they erroneously validated and reported discordant results on patient samples tested for (b)(6).The customer accepted "x- no result" results in the centralink data management system, then manually validated the results and uploaded a value of "(b)(6)" in the laboratory information system.The samples were repeated, and corrected results were issued to the physician(s).There are no reports of patient intervention or adverse health consequences due to the (b)(6) values reported.

• 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: 6189128
• MDR Text Key: 62857964
• Report Number: 2432235-2016-00782
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/20/2016

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: 11/22/2016
• 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
• Patient Sequence Number: 1