BEUDAMED
    FDA Adverse Event Other Summary report: N

    MOSAIQ

    MDR report key: 3261291 · Received July 31, 2013

    Report

    Report Number
    2950347-2013-00005
    Event Type
    Other
    Date Received
    July 31, 2013
    Report Date
    July 31, 2013
    Manufacturer
    IMPAC MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    PMA / PMN Number
    K123230
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER INCORRECTLY CREATED AN ORDER SET ON CIV DRUG THAT SHOWED THE AMOUNT TO BE GIVEN ON A SINGLE DAY OF A CIV THAT WAS TO BE GIVEN OVER 4 DAYS. THIS INCIDENT RESULTED IN A SIGNIFICANT UNDERDOSE IN A PATIENT THAT WAS NOT DETECTED UNTIL 28 DAYS AFTER ADMINISTRATION. IT IS UNKNOWN WHETHER THE UNDERDOSE RESULTED IN ADVERSE HEALTH CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357119 MOSAIQ ONCOLOGY INFORMATION SYSTEM (IYE) IYE IMPAC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other