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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CERNER CORPORATION CERNER IGNITE APIS FOR MILLENNIUM; SOFTWARE

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CERNER CORPORATION CERNER IGNITE APIS FOR MILLENNIUM; SOFTWARE Back to Search Results
Model Number ALL CERNER IGNITE APIS FOR MILLENNIUM RELEASES
Device Problem Computer Software Problem (1112)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2023
Event Type  malfunction  
Manufacturer Narrative
Cerner distributed a flash notification on december 20, 2023 to all potentially impacted client sites.The software notification includes a description of the issue and a software modification is being developed to address the issue for all sites that could be potentially 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 ignite apis for millennium®, 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 millennium ignite apis for millennium® allergies, cerner ignite apis for millennium, medication clinical decision support, seamless exchange.The issue involves cerner millennium ignite apis and affects users that utilize the allergies, cerner ignite apis for millennium, medication clinical decision support, seamless exchange to enable external applications to integrate into the millennium platform.In cerner millennium, when a snomed ct allergy was supplied for an allergy substance and a mapping did not exist between the selected snomed ct and a multum allergy category, the drug allergies saved to millennium with snomed ct nomenclature do not generate alerts.When the mapping was not found, a corresponding snomed ct nomenclature was used to add the allergy to millennium.A snomed ct allergy substance does not qualify for drug-allergy interaction checking, resulting in a possible patient care impact if a clinician were to prescribe a drug that interacts with the snomed ct allergy.Patient care could be adversely affected, if clinicians not being aware that the drug-allergy interaction checking was not occurring, prescribe a drug that does not properly trigger a drug allergy alert on the patient's profile.This issue could result in serious injury and patient care delay.Cerner has not received communication on any adverse patient events as a result of this issue.
 
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Brand Name
CERNER IGNITE APIS FOR MILLENNIUM
Type of Device
SOFTWARE
Manufacturer (Section D)
CERNER CORPORATION
8779 hillcrest road
kansas city MO 64138
Manufacturer (Section G)
CERNER CORPORATION
8779 hillcrest road
kansas city MO 64138
Manufacturer Contact
jeff mauzey
8779 hillcrest road
kansas city, MO 64138
MDR Report Key18388762
MDR Text Key331485917
Report Number1931259-2023-00019
Device Sequence Number1
Product Code LNX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Company Representative
Reporter Occupation Administrator/Supervisor
Remedial Action Modification/Adjustment
Type of Report Initial
Report Date 12/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberALL CERNER IGNITE APIS FOR MILLENNIUM RELEASES
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/29/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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