BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCKESSON CARDIOLOGY ECG MANAGEMENT

    MDR report key: 10398464 · Received August 12, 2020

    Report

    Report Number
    9616760-2020-00003
    Event Type
    Injury
    Date Received
    August 12, 2020
    Report Date
    November 3, 2020
    Manufacturer
    MCKESSON ISRAEL LTD.
    Product Code
    DQK
    UDI-DI
    80010939040011
    PMA / PMN Number
    K113515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MCKESSON CARDIOLOGY ECG MANAGEMENT DISPLAYS THE ECG WAVEFORMS ALONG WITH ECG INTERVALS AND MEASUREMENTS. THE MEASUREMENTS CAN BE DISPLAYED BY ONE OF THE FOLLOWING CONFIGURATIONS: 1. GLASGOW UNIVERSITY INTERPRETIVE ALGORITHM, WHICH IS A WIDELY USED ALGORITHM FOR AUTOMATED ECG. 2. IMPORTING THE MEASUREMENT VALUE FROM AN ECG CART, WHICH IS A DIFFERENT DEVICE COMMUNICATING WITH THE MCKESSON CARDIOLOGY ECG MANAGEMENT SYSTEM. IN ADDITION, THE USER CAN MANUALLY MEASURE THE INTERVALS USING A MEASUREMENT TOOL AND EDIT THE VALUE WHICH IS DISPLAYED BY THE SELECTED OPTION (GLASGOW OR CART). THE REPORTING PHYSICIAN CLAIMED THAT THE AUTOMATIC MEASUREMENT OF THE QT INTERVAL PRESENTED A FALSELY PROLONGED VALUE. CHANGE HEALTHCARE HAS UNSUCCESSFULLY MADE MULTIPLE ATTEMPTS TO CONTACT THE CUSTOMER TO IDENTIFY WHICH CONFIGURATION WAS USED WHEN THE REPORTED INCIDENT OCCURRED (GLASGOW/ CART). CHANGE HEALTHCARE HAS RE-TESTED THE ECG MANAGEMENT QT INTERVAL CALCULATION PERFORMED BY GLASGOW ALGORITHM. TESTING AGAINST THE PRODUCT SPECIFICATIONS PASSED SUCCESSFULLY WITH THE CORRECT RESULTS. THE REPORTING PHYSICIAN CLAIMED THAT THE MEDICAL STAFF BASED THEIR DECISION TO DELAY THE ADMINISTRATION OF THE MEDICATION ON THE AUTOMATED QT VALUE DISPLAYED. THE REPORTING PHYSICIAN FURTHER STATED THAT FOLLOWING HIS REVIEW OF THE ECG WAVEFORMS AND INTERVAL, THE PATIENT WAS PRESCRIBED MEDICATION. THE CHANGE HEALTHCARE ECG MANAGEMENT USER GUIDE CAUTIONS THAT THE OVER- READING PHYSICIAN MUST ALWAYS RELY ON CLINICAL JUDGMENT IN CONCLUDING A DIAGNOSIS FOR THE PATIENT. THE COMPANY CONCLUDED THAT THE SYSTEM PERFORMED AS INTENDED AND NO DEVICE MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT THE ONCOLOGY MEDICAL STAFF DELAYED A MEDICATION ADMINISTRATION TO A PEDIATRIC PATIENT DUE TO PROLONGED AUTOMATED QTC VALUES THAT WERE PRESENTED IN A REPORT CREATED BY THE MCKESSON ECG MANAGEMENT SYSTEM. THE REPORTING PHYSICIAN FURTHER CLAIMS THAT FOLLOWING HIS CONSULTATION THE PATIENT EVENTUALLY RECEIVED THE MEDICATION AND IS NOW RECEIVING APPROPRIATE CARE.

    Additional Manufacturer Narrative · 1

    THE EVENT IS CURRENTLY UNDER INVESTIGATION TO DETERMINE WHETHER THE DEVICE HAS MALFUNCTIONED. CHANGE HEALTHCARE WILL PROVIDE A FOLLOW UP REPORT TO THE AGENCY ONCE ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT THE ONCOLOGY MEDICAL STAFF DELAYED A MEDICATION ADMINISTRATION TO A PEDIATRIC PATIENT DUE TO PROLONGED AUTOMATED QTC VALUES THAT WERE PRESENTED IN A REPORT CREATED BY THE MCKESSON ECG MANAGEMENT SYSTEM. THE REPORTING PHYSICIAN FURTHER CLAIMS THAT FOLLOWING HIS CONSULTATION THE PATIENT EVENTUALLY RECEIVED THE MEDICATION AND IS NOW RECEIVING APPROPRIATE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863151 MCKESSON CARDIOLOGY ECG MANAGEMENT MCKESSON CARDIOLOGY ECG MANAGEMENT DQK MCKESSON ISRAEL LTD. 13.2.1. 80010939040011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other