BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    CHANGE HEALTHCARE CARDIOLOGY

    MDR report key: 19657694 · Received July 2, 2024

    Report

    Report Number
    8022257-2024-00001
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    January 8, 2024
    Report Date
    June 11, 2024
    Manufacturer
    CHANGE HEALTHCARE CANADA COMPANY
    Product Code
    LLZ
    UDI-DI
    17540262090116
    PMA / PMN Number
    K212528
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER A CHANGE HEALTHCARE CARDIOLOGY SYSTEM UPGRADE, THE CUSTOMER IMMEDIATELY NOTICED THAT STUDIES WERE FILTERED INCORRECTLY BY THE DATE/TIME ON THE WORKLIST. THE INVESTIGATION REVEALED THAT THE CUSTOMER WAS USING AN UNAPPROVED CONFIGURATION, WHERE THE REGIONAL SETTINGS ON THE SERVER AND CLIENT/BROWSER SIDE WERE NOT ALIGNED. IN A SPECIFIC WORKFLOW, WHERE PROCEDURE INFORMATION IS MANUALLY MODIFIED, THIS UNAPPROVED CONFIGURATION CAN RESULT IN INCORRECT DATES, WITH THE MONTH AND DAY INFORMATION BEING SWITCHED. THE COMPANY'S LABELING (WEB CLIENTS INSTALLATION GUIDE 15.0, VERSION 6) INCLUDES SPECIFIC INSTRUCTIONS REGARDING THE IMPORTANCE OF ALIGNING THE REGIONAL SETTINGS. HOWEVER, THE INVESTIGATION FOUND THAT THE CUSTOMER HAD RECEIVED AN EARLIER VERSION OF THE LABELING (VERSION 4), WHICH WAS THE LATEST RELEASE AT THE TIME, BUT DID NOT EXPLICITLY OUTLINE THIS INFORMATION. THE ROOT CAUSE OF THE ISSUE WAS IDENTIFIED AS A CONFIGURATION ERROR DUE TO MISALIGNED REGIONAL SETTINGS BETWEEN THE SERVER AND THE CLIENT/BROWSER. THIS MISALIGNMENT OCCURRED BECAUSE THE CUSTOMER WAS USING AN UNAPPROVED CONFIGURATION THAT WAS NOT EXPLICITLY ADDRESSED IN THE VERSION OF THE PRODUCT LABELING THEY RECEIVED. CONSEQUENTLY, IN WORKFLOWS INVOLVING MANUAL MODIFICATION OF PROCEDURE INFORMATION, THIS CONFIGURATION ERROR LED TO THE INCORRECT SWITCHING OF MONTH AND DAY INFORMATION IN DATES. THE CUSTOMER'S CHANGE HEALTHCARE CARDIOLOGY SYSTEM'S CONFIGURATION HAS BEEN UPDATED AND A CAPA HAS BEEN FILED TO ADDRESS THE ROOT CAUSE OF THIS ISSUE. THE CUSTOMER SUBSEQUENTLY HAS BEEN PROVIDED WITH THE CORRECT DOCUMENTATION FOR WEB CLIENTS INSTALLATION GUIDE VERSION 6, TO PREVENT ANY FURTHER MISCONFIGURATIONS. A PLANNED RECALL WILL BE INITIATED TO ADDRESS THE LABELING DEFICIENCY. JUNE 25, 2024. CHANGE HEALTHCARE INITIALLY SUBMITTED THIS MDR ON JUNE 12TH, 2024 VIA FED-EX (FEDEX TRACKING: (B)(6)). CHANGE HEALTHCARE RECEIVED A REJECTION EMAIL ON JUNE 24TH, 2024 FOR THIS SUBMISSION AS THE FDA NO LONGER ACCEPTS HARDCOPY SUBMISSIONS. TECHNICAL CHALLENGES HAVE DELAYED OUR ABILITY TO ELECTRONICALLY FILE THIS SUBMISSION VIA THE ESG PORTAL.

    Description of Event or Problem · 0

    THE CUSTOMER WAS USING CHANGE HEALTHCARE CARDIOLOGY 15.0.1 AND REPORTED THAT STUDIES WERE BEING FILTERED INCORRECTLY BY THE DATE/TIME ON THE WORKLIST. THE CUSTOMER NOTICED THAT TWO PATIENTS HAD STUDIES WITH THIS ISSUE. THERE WERE NO REPORTED ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601962 CHANGE HEALTHCARE CARDIOLOGY PACS LLZ CHANGE HEALTHCARE CANADA COMPANY 15.0.1 17540262090116

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown