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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Communication or Transmission Problem (2896)

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

Event Date 12/15/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center.A siemens specialist was dispatched to the customer's site and performed a study on an atellica solution.After the specialist completed the study, the specialist returned the atellica solution into an operating state and uploaded quality control (qc) to a centralink data management system.The issue occurred when the centralink data management system incorrectly interpreted the qc lot number.Siemens is investigating the issue.The software driver that the centralink data management system uses to communicate with the atellica solution modules potentially contributed to the event.Mdr 2432235-2020-00035 is associated with this issue.

Event Description

A centralink data management system incorrectly interpreted the quality control (qc) lot number that was transmitted by an atellica solution module.When this issue occurs, new qc populations (which are usually generated when the customer inserts a new lot number of qc material into use) are created under an incorrect lot number.By default, the new qc populations are not associated with acceptable ranges.In the event that qc recovers unacceptably, patient results could be released inappropriately.There are no known reports of discordant patient results, delay to patient testing, patient intervention or adverse health consequences due to this issue.

Manufacturer Narrative

Siemens filed initial mdr 2432235-2020-00036 on (b)(6) 2020 and the first supplemental mdr (b)(6)2020.Additional information (b)(6) 2020): siemens healthcare diagnostics has identified an unexpected interface driver behavior in centralink data management system when quality control (qc) is processed on atellica solution while the communication with centralink is interrupted.This issue can only occur when centralink is directly connected to an atellica solution consisting of at least two (2) analyzer modules, and atellica solution control ids are different than the control lot number.When this happens, all qc results for a control id are sent to centralink in one result message after the interface communication is re-established.The qc results from the first analyzer module serial number listed in the result message are not affected by this issue.However, once the driver recognizes a different analyzer module serial number in the result message, it assigns qc results to an incorrect control lot number matching the control id.This unexpected behavior continues for all remaining qc results in the result message.As a result of the unexpected behavior described above, the newly created control lot number (matching the control id) will not have target values or qc rules assigned, so qc results may not be properly evaluated for pass/fail criteria.Any rules that may be configured to hold patient results upon qc failure may not be properly evaluated.Starting (b)(6)2020, an urgent medical device correction (umdc) isw-20-01.A.Us was sent to us customers and an urgent field safety notice (ufsn) isw-20-01.A.Ous was sent to outside the us (ous) customers in may of 2020.The umdc and ufsn recommend that the customer review qc results in the centralink daily and use the control lot number as the control id.The umdc and ufsn also deter the customer from processing qc when the interface communication is interrupted.Additionally, the umdc and ufsn indicate that siemens will contact all affected customers to schedule a date to update the interface communication driver.The result and conclusion codes in section h6, section h7, and section h9 were updated to reflect the additional information.Mdr 2432235-2020-00035_s2 was filed for the same issue.

Manufacturer Narrative

Siemens filed initial mdr on 10-jan-2020.Additional information (10-feb-2020): siemens further investigated the issue and determined that adding order records are expected when the driver processes a message containing results from more than one atellica solution module.This is required so that quality control (qc) results are correctly stored with their associated module's serial number in the centralink qc application.For qc results, the qc identifier is extracted from the qc lot field and when a qc result from a different module is encountered in the message, a new order record is created as required.However, there is a potential for the centralink data management system driver to extract the sample id from the order record, instead of from the qc lot field.When this occurs, the qc results will be stored under the sample id, rather than the lot number.The centralink data management system performed as intended after the customer manually corrected the qc lot numbers in the centralink qc application.Mdr 2432235-2020-00035_s1 was filed for the same issue.

• 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: 9578647
• MDR Text Key: 193979613
• Report Number: 2432235-2020-00036
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CENTRALINK DATA MANAGEMENT SYSTEM
• Device Catalogue Number: 11314337
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 02/10/2020; 05/11/2020
• Supplement Dates FDA Received: 03/09/2020; 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2432235-05/20/2020-009-C
• Patient Sequence Number: 1