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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Output Problem (3005)

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

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center.The precision study was run under sample id (b)(6) on a dimension vista instrument.Based on the service logs, siemens determined that the barcode translator used the last cached sample id (instead of (b)(6)) and associated the last cached sample id with the results from the precision study.The barcode translator on the centralink data management system was adjusted; a change was made to the rule which differentiated quality control results from patient results.The cause of the event is unknown.Based on siemens understanding, the customer has not tested the rule.No further evaluation of this device is required.

Event Description

A centralink data management system, connected to multiple dimension vista instruments, displayed precision test results from one dimension vista instrument as patient results ordered from another dimension vista instrument, instead of the results obtained on the patient samples.The centralink data management system displayed an ammonia precision result as a test result for sample id (b)(6) and a glucose precision result as a test result for sample id (b)(6).The ammonia precision result was not reported to the physician(s) as the lab technician noticed the incorrect result, while the glucose precision result was reported to the physician(s).The results obtained on the patient samples were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the incorrect results that were displayed on the centralink data management system.

Manufacturer Narrative

Siemens filed initial mdr 2432235-2019-00306 on 27-aug-2019.Additional information (21-nov-2019): siemens further investigated the issue.Siemens determined that the communication issue between the dimension vista instruments and the centralink data management system was an isolated event, which was resolved with the configuration change in the barcode translator.The cause of the event is unknown.The device is performing according to specifications.No further evaluation of this device is required.

• Brand Name: CENTRALINK DATA MANAGEMENT SYSTEM
• Type of Device: CENTRALINK DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 8937608
• MDR Text Key: 209794266
• Report Number: 2432235-2019-00306
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

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
• Device Catalogue Number: 10816521
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1