MAUDE Adverse Event Report: CERNER CORPORATION MEDICAL DEVICE INTERFACES; SOFTWARE

Model Number N/A

Device Problems Computer Software Problem (1112); Data Problem (3196)

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

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

This issue is isolated to one client, and cerner notified this client of the issue on december 19, 2017.The same day, cerner corrected the configuration and the issue was resolved.Cerner corporation considers this issue to be resolved and no further narrative is required for follow-up.

Event Description

The issue involves cerner millennium medical device interfaces (mdi) which provides electronic communication between the lab testing instrument and cerner millennium pathnet system.Due to an incorrect configuration in mdi, when an order was placed for digoxin dta in pathnet, the lab testing instrument ran the dta for creatinine.The test result values for the creatinine dta were saved in pathnet as digoxin levels.Patient care could be adversely affected as clinicians may adjust the dosage of digoxin based on incorrect information which could lead to the patient receiving an overdose or underdose of the medication.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: MEDICAL DEVICE INTERFACES
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rockcreek parkway; kansas city MO 64117
• Manufacturer (Section G): CERNER CORPORATION; 2800 rockcreek parkway; kansas city MO 64117
• Manufacturer Contact: shelley looby ; 2800 rockcreek parkway; kansas city, MO 64117 ; 8162011368
• MDR Report Key: 7186765
• MDR Text Key: 97752359
• Report Number: 1931259-2018-00001
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1