MAUDE Adverse Event Report: CERNER CORPORATION MULTUM; SOFTWARE

Model Number V254 - V260

Device Problem Application Program Problem: Medication Error (3198)

Patient Problems Skin Irritation (2076); Torsades-de-Pointes (2107); Electrolyte Imbalance (2196)

Event Date 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a priority review flash notification flash19-0421-0 on june 28, 2019 to all potentially impacted client sites.The software notification includes a description of the issue and notice that a software modification is being developed to address the issue for all sites that could potentially be impacted.  cerner corporation will provide a follow-up report when the software modification is available.

Event Description

The software product mentioned in this medwatch report may not be, by definition, a medical device; however, cerner has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product.  the company's filing of this medwatch report does not signify cerner's belief or understanding that medical device reports are required to be filed for products such as cerner's multum®, nor are these products currently actively regulated by the fda.  this report documents information related to an issue identified with functionality included in cerner's multum® drug content.  the issue involves cerner multum®  and affects users that utilize drug content for drug interaction checking. new drug numbers were created for the drugs suprep and gleolan and drug interaction checks were either omitted or incorrectly categorized.As a result, there is a potential that drug interaction alerts may not display when prescribing these medications.  patient care could be adversely affected, as clinicians may prescribe incompatible drugs resulting in adverse reaction.This issue could result in serious injury to the patient.Cerner has not received communication on any adverse patient events as a result of this issue. .

Manufacturer Narrative

Cerner distributed a priority review flash notification flash19-0421-1 on july 8, 2019 to all potentially impacted client sites.The software notification includes a description of the issue and notice that a software modification has been developed to address the issue for all sites that could potentially be impacted.Cerner corporation considers this issue to be resolved and no further narrative is required for follow-up.

Event Description

The software product mentioned in this medwatch report may not be, by definition, a medical device; however, cerner has chosen to file this medwatch report in order to voluntarily notify the fda of a malfunction associated with this software product.The company's filing of this medwatch report does not signify cerner's belief or understanding that medical device reports are required to be filed for products such as cerner's multum®, nor are these products currently actively regulated by the fda.This report documents information related to an issue identified with functionality included in cerner's multum® drug content.The issue involves cerner multum® and affects users that utilize drug content for drug interaction checking.New drug numbers were created for the drugs suprep and gleolan and drug interaction checks were either omitted or incorrectly categorized.As a result, there is a potential that drug interaction alerts may not display when prescribing these medications.Patient care could be adversely affected, as clinicians may prescribe incompatible drugs resulting in adverse reaction.This issue could result in serious injury to the patient.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: MULTUM
• Type of Device: SOFTWARE
• Manufacturer (Section D): CERNER CORPORATION; 2800 rock creek parkway; kansas city MO 64117
• MDR Report Key: 8761035
• MDR Text Key: 209176084
• Report Number: 1931259-2019-00003
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V254 - V260
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1