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 Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens specialist and indicated that they manually released critically low and elevated sodium results from the centralink data management system.The customer reported that the centralink data management system appropriately held these results, classified these results with severity values of 3 or higher, and highlighted these results in red.However, the review and edit window of the centralink data management system has a feature which highlights the top line result in blue to indicate that the result has been selected.The customer reported that they released critical sodium patient results due to the blue highlight feature, as it masked the red highlighted sodium results.The customer reported that they missed the severity values, classifying the critical results, when releasing these results to the physician(s).To accommodate this use error, a siemens specialist programmed a dummy test to rest on the top line of the review and edit window.The centralink data management system was performing according to specifications.The customer's method in manually reporting results contributed to the critical sodium results that were released to the physician(s).The system is performing according to specifications.No further evaluation of this device is required.

Event Description

The customer reported that they manually released critically low and elevated sodium patient results that were held by the centralink data management system.The customer calculated that they released 7.3% of critically low sodium results and 5% of critically elevated sodium results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the critical sodium patient results released by the customer.

Manufacturer Narrative

Siemens filed the initial mdr on 03-may-2019.Additional information (06-may-2019): the customer indicated that they did not send a report to the fda.Section of this report was revised to reflect the additional information.The system is performing according to specifications.No further evaluation of this device is required.

Manufacturer Narrative

Siemens filed initial mdr 2432235-2019-00158 on 03-may-2019, the initial supplemental report on 30-may-2019, the second supplemental report on 05-jul-2019, and the third supplemental report 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.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 2432235-2019-00256_s1 were filed for the same issue.

Manufacturer Narrative

Siemens filed initial mdr 2432235-2019-00158 on 03-may-2019, first supplemental mdr on 30-may-2019, and second supplemental mdr on 05-jul-2019.The initial mdr indicates that the customer manually released critically low and elevated sodium patient results that were held by the centralink data management system.The customer calculated that they released 7.3% of critically low sodium results and 5% of critically elevated sodium results to the physician(s).Corrected information (12-jul-2019): the customer reported that they did not provide appropriate attention to critical 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 releasing the results to the physician(s).The customer attributed missing these 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.The customer calculated that they released 7.3% of critically low sodium results and 5% of critically elevated sodium results to the physician(s) without taking additional appropriate actions.Section b5 was updated to reflect the corrected information.Additional information (23-jul-2019): the customer reported that they did not alert physician(s) of critically elevated sodium results for 30 additional patients.The customer reported that there was no evidence of impact to patient care due to special attention not being paid to these critically elevated sodium results.Section b5 was updated to reflect the additional information.The second supplemental mdr indicates that the customer alleged that seven (7) patient had a delay in patient care and one (1) of the 7 patients appeared to be impacted due to the delay in patient care.The customer clarified that these results were released from alternate devices at other sites.Mdr 2432235-2019-00254, mdr 2432235-2019-00255, and mdr 2432235-2019-00256 were filed for the same issue.

Event Description

The customer reported that they did not provide appropriate attention to critical 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 releasing the results to the physician(s).The customer attributed missing these 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.The customer calculated that they released 7.3% of critically low sodium results and 5% of critically elevated sodium results to the physician(s) without taking additional appropriate actions.The customer reported that they did not alert physician(s) of critically elevated sodium results for 30 additional patients.The customer reported that there was no evidence of impact to patient care due to special attention not being paid to 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 the initial mdr 2432235-2019-00158 on 03-may-2019 and the initial supplemental mdr on 30-may-2019.Additional information (11-jun-2019): the customer reported that they reviewed fifty (50) medical charts in which critical sodium results were not called to healthcare providers.The customer indicated that for most patients, there was no clinical impact.The critical results were either seen by healthcare providers or healthcare providers were already informed of critical results for those patients based on previous results that were called in.The customer alleged that seven (7) out of fifty patients had a delay in patient care and the customer alleged that one (1) out of the fifty patients appeared to be impacted due to the delay in patient care.Siemens requested additional information regarding the impact to patient care due to this issue multiple times, however, the customer has not provided additional details.Siemens further investigated the information provided by the customer.A siemens specialist confirmed the customer's observation regarding the blue highlight feature.Despite the blue highlight feature, siemens determined that the severity values associated with the critical results are displayed and are visible to the operator.The centralink data management system operator's guide provides instructions in customizing colors to make results more visible to operators.The system 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: 8578797
• MDR Text Key: 145236181
• Report Number: 2432235-2019-00158
• 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,Followup,Followup,Followup
• Report Date: 10/02/2019

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: 04/08/2019
• Initial Date FDA Received: 05/03/2019
• Supplement Dates Manufacturer Received: 05/06/2019; 06/11/2019; 07/12/2019; 09/24/2019
• Supplement Dates FDA Received: 05/30/2019; 07/05/2019; 08/05/2019; 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1