MAUDE Adverse Event Report: CERNER CORPORATION CERNER MULTUM DRUG DATABASE; SOFTWARE

Model Number V234-V236

Device Problem Device Issue (2379)

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

Event Date 06/09/2017

Event Type  malfunction  

Manufacturer Narrative

Cerner distributed a flash notification flash17-0375-1 on july 6, 2017 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 sofware 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 drug database or millennium powerchart 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 database and manifested millennium powerchart.The issue involves cerner multum drug database and affects information documented in cerner millennium powerchart.When a user enters an allergy as free-text in a patient's chart, the numeral 0 is displayed in the patient's chart instead of the allergy entered in the free-text field.Patient care could be adversely affected if a patient is administered a substance to which they are allergic.Cerner has not received communication on any adverse patient events as a result of this issue.

Manufacturer Narrative

Cerner distributed a flash notification flash17-0375-1 on july 6, 2017 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 distributed a flash notification flash17-0375-4 on october 11, 2017 to all potentially impacted client sites.The software notification was updated to include notification that a software modification has been developed and is available to address the issue for all sites that could be potentially impacted.Cerner corporation considers the issue 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 drug database® or millennium powerchart®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 database and manifested millennium powerchart.The issue involves cerner multum drug database and affects information documented in cerner millennium powerchart.When a user enters an allergy as free-text in a patient's chart, the numeral 0 is displayed in the patient's chart instead of the allergy entered in the free-text field.Patient care could be adversely affected if a patient is administered a substance to which they are allergic.Cerner has not received communication on any adverse patient events as a result of this issue.

• Brand Name: CERNER MULTUM DRUG DATABASE
• 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: 6691653
• MDR Text Key: 79255864
• Report Number: 1931259-2017-00002
• 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,Followup
• Report Date: 10/27/2017

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: V234-V236
• 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
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 07/06/2017
• Supplement Dates Manufacturer Received: 06/09/2017
• Supplement Dates FDA Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2017
• 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