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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANATOMIC PATHOLOGY; SOFTWARE

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ANATOMIC PATHOLOGY; SOFTWARE Back to Search Results
Model Number 2018.01
Device Problem Computer Software Problem (1112)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2021
Event Type  malfunction  
Manufacturer Narrative
Cerner distributed a flash notification on august 05, 2021 to all potentially impacted client sites.The software notification includes a description of the issue and a software modification has been 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 anatomic pathology®, 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 anatomic pathology® case findings,image management, order result viewer, pathology history entry, pathology history inquiry, powerchart.The issue involves cerner millennium anatomic pathology and affects users that utilize the case findings, image management, order result viewer, pathology history entry, pathology history inquiry, powerchart to for storing and reporting pathology information for clinical areas such as, but not limited to: surgical pathology, autopsy, cytology, and bone marrow pathology.Anatomic pathology is intended for use by pathologists, cytotechnologists, histotechnologists, and others certified in laboratory science.In cerner millennium, when the pathology report details are not displayed in anatomic pathology result inquiry applications for uploaded historical cases with data in a format other than rtf.Patient care could be adversely affected, because the inability to view a patient's pathology history may cause a delay in reporting the current pathology case.This issue could result in patient care delay.
 
Manufacturer Narrative
Cerner distributed a flash notification on august 05, 2021 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 distributed a flash notification on october 7, 2021 to all potentially impacted client sites.The software notification includes a description of the issue and indicates that software modification has been developed to address the issue for all sites that could be potentially 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 anatomic pathology®, 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 anatomic pathology® anatomic pathology.The issue involves cerner millennium anatomic pathology and affects users that utilize the anatomic pathology for storing and reporting pathology information.In cerner millennium, when uploaded historical cases are viewed that are in a format other than rich text format (rtf), the report details are not displayed in anatomic pathology result inquiry applications.Patient care may be affected because the inability to view a patient's pathology history may cause a delay in reporting the current pathology case.Cerner has not received communication on any adverse patient events as a result of this issue.
 
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Brand Name
ANATOMIC PATHOLOGY
Type of Device
SOFTWARE
MDR Report Key12284870
MDR Text Key265390707
Report Number1931259-2021-00014
Device Sequence Number1
Product Code LNX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Remedial Action Modification/Adjustment
Type of Report Initial,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2018.01
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2021
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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