MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK DATA MANGEMENT SYSTEM; LABORATORY INFORMATION SYSTEM

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).A siemens technical services technician evaluated the centralink database management system (centralink).The patient's initial test was held for review by centralink and flagged correctly for the severity of the test result.The operator did not notice the flagging and released the result immediately to the physician(s).The patient was called back for retesting and the patient left the clinic and could not come back for approx.5-7 hours.The delay in reporting the critically low sodium test result was due an operator error of not recognizing the test result was flagged in centralink.The instrument is operating within manufacturing specifications.No further evaluation of the device is required.

Event Description

The customer contacted siemens to report a sodium (na) test result, that should have been held, was released to the physician(s) by the operator.The sodium test result was in the critically low range, and flagged by the centralink database management system (centralink).After a delay of approximately 5 hours, the patient was recalled to have a second sample drawn.The second test result matched the initial critically low result and was reported to the physician without delay.The patient was referred to an emergency room and reportedly received sodium repletion.There were no reports of adverse health consequences due to the delay in testing.

Manufacturer Narrative

Siemens filed initial mdr 2432235-2019-00145 on 19-apr-2019.Corrected information (16-oct-2019): the initial mdr indicated that a sodium result that should have been held, was released to the physician(s) by the operator.It needs to be clarified that the customer reported that they did not provide appropriate attention to the critical sodium results displayed on the "review and edit" window of the centralink data management system for sample id (b)(6) and sample id (b)(6).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 releasing the results to the physician(s).The customer attributed missing the critical results to a blue highlight feature on the system, which indicates 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 the patient test results were flagged with the correct severity of the test result.Additional information (16-oct-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.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 was reminded that there are other alerts available, as indicated in the operator guide, and visible for the operator to decide additional actions for the result.Siemens provided a dummy test to rest on the top row of the "review and edit" screen in the centralink data management system.Therefore, the first row (dummy test), which will not contain results, will be highlighted in blue background color when the "review and edit" screen is first opened.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.The device is performing according to specifications.No further evaluation of this device is required.

• Brand Name: CENTRALINK DATA MANGEMENT SYSTEM
• Type of Device: LABORATORY INFORMATION SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8532811
• MDR Text Key: 143979552
• Report Number: 2432235-2019-00145
• 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: 10/21/2019

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: 03/26/2019
• Initial Date FDA Received: 04/19/2019
• Supplement Dates Manufacturer Received: 10/16/2019
• Supplement Dates FDA Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 MO