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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem No Device Output (1435)

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

Event Date 08/30/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Siemens investigated the system's files and determined that the system produced the error messages 33 times on the day of the event.Siemens changed a line of code that potentially caused the delay on the affected system.A siemens customer service engineer (cse) rebooted the centralink data management system sever three times and after the third time, the centralink data management system performed according to specifications.The cause of the delay in patient testing is unknown.Siemens is investigating the issue.

Event Description

The customer reported that there was a delay in patient testing for 1 hour and 30 minutes, which resulted in a delay to patient care, due to a centralink data management system.Centralink data management system was not importing test orders from a laboratory information system (lis) and was not uploading results from the connected instruments.After receiving the immunoglobulin g (igg), immunoglobulin a (iga), and immunoglobulin m (igm) results from a dimension vista instrument for sample (b)(6), the centralink data management system produced two errors messages: "attempt to update wb_myrequest record data exceeding 32000 (12370)" and "unable to update nb_myrequest field (142)".The customer reported that these error messages were obtained on other patient samples, but did not provide the tests ordered for the other samples.The customer reported that they manually ran samples on the connected instruments and released results to physician(s) via phone for 1 hour and 30 minutes.For sample (b)(6), the customer sent the results from the dimension vista instrument and uploaded the results to the lis.There are no known reports of adverse health consequences due to the delay in patient testing.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2018-00348 on 19-sep-2018.Additional information (03-oct-2018): siemens further investigated the issue.Siemens determined that a setting on the centralink data management system was not correctly configured and put the orders/tests requested for sample id (b)(4) in an unknown status.The issue was resolved by correcting the setting in the centralink data management system, as mentioned in the initial mdr.The result code and conclusion code of section h6 was updated to reflect the additional information.The instrument 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: 7890747
• MDR Text Key: 121565919
• Report Number: 2432235-2018-00348
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

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
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 10/03/2018
• Supplement Dates FDA Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1