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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center.The customer reported that the centralink data management system appropriately held the results, classified the results with numerical severity values that are assigned to critical results, and highlighted these results in red.The feature that highlights results in blue, to indicate that a row on the "review and edit" window has been selected, masked the red indicator.Siemens determined that other alerts (such as the numerical severity values) were available and visible for the operator to decide appropriate actions on the results.The centralink data management system was performing according to specifications.The customer's method in releasing results contributed to the event.Siemens medical affairs representatives evaluated the information provided by the customer.Per siemens understanding of clinical practice, it is standard laboratory practice for manual result review to include the review of each individual result and associated error messages, flags, and alerts.The mandatory review should indicate to the customer to take appropriate actions and call the medical provider due to the numerical severity flag.It is also siemens understanding of clinical practice that in critical settings, such as the emergency department or in cases where physical symptomologies are present, close monitoring of laboratory results would occur without laboratory notifications; critical results are typically also marked in the electronic medical record with visual cues, such as exclamation points, to increase the medical provider awareness.The device is performing according to specifications.No further evaluation of this device is required.Mdr 2432235-2019-00254, mdr 2432235-2019-00255, and mdr 2432235-2019-00158 were filed for the same issue.

Event Description

The customer reported that they did not provide appropriate attention to two (2) critically low sodium results displayed on the "review and edit" window of the centralink data management system.The customer indicated that these critical results required special attention, and the lab should have called/alerted the medical team or repeated the specimen (if appropriate) when they released the results to the physician(s).The customer attributed missing these critical results and not providing special attention to these critically low sodium results to a blue highlight feature on the system, which is intended to demonstrate the selection of a row on the table, since the blue highlight feature masked the red indicator on the "review and edit" window.The red indicator is feature that visibly alerts the operator of a result that requires special attention.In addition to the red indicator, the centralink data management system assigned numerical severity values to flag these critical results.However, the customer did not notice the numerical severity values and released the critical sodium results without taking additional appropriate actions for the critical results.The customer reported that patient care was delayed for the two patients due to this issue.The customer also reported that they did not call/alert physician(s) of critically elevated sodium results when releasing the results for 30 additional patients.The customer reported that there was no evidence of impact to patient care due to missing these critically elevated sodium results.There are no known reports of patient intervention or adverse health consequences due to this issue.

Manufacturer Narrative

Siemens filed initial mdr 2432235-2019-00256 on 05-aug-2019.Additional information (24-sep-2019): it was determined that the critical sodium (na) results released without taking additional actions required for critical results were on the top row of the centralink data management system's "review and edit" screen and highlighted in blue.As a troubleshooting measure, siemens provided the following instructions to the customer: enter a dummy test so that the first row, which does not contain results, will be highlighted in blue background color when the "review and edit" screen is first opened.Therefore, patient results in the "review and edit" screen will not be highlighted in blue unless the customer moves the cursor to select a particular row.Furthermore, siemens communicated to the customer that the centralink data management system highlights the top result row in blue as an indication that the result has been selected and that the blue highlight covers any other color for the test result, including red.The customer has been informed that there are other alerts available and visible for the operator to decide additional actions for the result.The device is performing according to specifications.No further evaluation of this device is required.Mdr 2432235-2019-00254_s1, mdr 2432235-2019-00255_s1, and mdr 2432235-2019-00158_s4 were 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: 8862171
• MDR Text Key: 203541955
• Report Number: 2432235-2019-00256
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• 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
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1