BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HNA MILLENNIUM PHARMNET

    MDR report key: 379455 · Received February 21, 2002

    Report

    Report Number
    1931259-2002-00002
    Event Type
    Malfunction
    Date Received
    February 21, 2002
    Date of Event
    February 6, 2002
    Report Date
    February 20, 2002
    Manufacturer
    CERNER CORP.
    Product Code
    MMH
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ISSUE INVOLVES THE PHAMEDMGR.EXE APPLICATION USED WITHIN THE MILLENNIUMM PHARMNET SYSTEM. THE ISSUE OCCURS WHEN THE USER ENTERS A VERY SMALL DOSE THAT RESULTS IN THE CALCULATION OF A VOLUME THAT IS SMALLER THAN 2 SIGNIFICANT DIGITS. UNDER CERTAIN CONDITIONS, THE VOLUME CALCULATION MAY ROUND INCORRECTLY. CURRENTLY, VOLUME CALCULATIONS ARE SUPPORTED DOWN TO 2 DECIMAL PLACES OF PRECISION. THE BEHAVIOR WAS OBSERVED TO OCCUR WHEN AN ORIGINAL DOES WAS UPDATED AND THE RESULTING VOLUME CALCULATION EXTENDED BEYOND 2 DECIMAL PLACES. IF THE DOSE REQUIRES GREATER THAN 2 DECIMAL POINTS OF PRECISION, THE VOLUME DISPLAYED TO THE USER IS 0, BUT THE APPLICATION WRITES TO THE DATABASE THE PREVIOUS VALID VOLUME AND THE NEW STRENGTH OF THE INGREDIENT. THUS THE RATIO OF THE INGREDIENT'S STRENGTH NO LONGER MATCHES THE INGREDIENT'S VOLUME. CERNER HAS NOT BEEN MADE AWARE OF ANY ADVERSE PATIENT CARE THAT RESULTED FROM THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HNA MILLENNIUM PHARMNET SOFTWARE MMH CERNER CORP. RELEASE 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *