BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTOOL IV

    MDR report key: 8649269 · Received May 29, 2019

    Report

    Report Number
    3009864844-2019-00001
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Manufacturer
    MONARCH MEDICAL TECHNOLOGIES
    Product Code
    NDC
    PMA / PMN Number
    K132547
    Removal / Correction Number
    3009864844-5/9/2019-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AFFECTED CUSTOMER SITES HAVE BEEN NOTIFIED OF THE SOFTWARE BUG. A PATCH WAS CREATED AND VALIDATED FOR ENDOTOOL IV VERSIONS 1.8.5 AND HIGHER. THE AFFECTED CUSTOMER SITES ARE BEING UPGRADED.

    Description of Event or Problem · 1

    A SOFTWARE BUG WAS DISCOVERED IN ENDOTOOL IV VERSION 1.10. THIS BUG IS IN AN AREA OF THE SOFTWARE THAT ADDRESSES PERSISTENTLY ELEVATED GLUCOSE LEVELS. INVESTIGATION AND ANALYSIS OF THE BUG HAS DETERMINED IT IS VERY UNLIKELY TO RE-OCCUR. IN THE VERY UNLIKELY EVENT IT DOES RE-OCCUR, IT COULD CAUSE THE SOFTWARE TO INCORRECTLY CALCULATE AN INSULIN DOSE RECOMMENDATION. INVESTIGATION DETERMINED THERE HAS BEEN ONLY ONE OCCURENCE OF THE BUG. THE DOSE RECOMMENDATION WAS CORRECTLY NOT ACCEPTED BY THE BEDSIDE CAREGIVER AND THERE WAS NO ASSOCIATED PATIENT HARM. ALL AFFECTED CUSTOMER SITES HAVE BEEN NOTIFIED OF THE SOFTWARE BUG. A PATCH WAS CREATED AND VALIDATED FOR ENDOTOOL IV VERSIONS 1.8.5 AND HIGHER. THE AFFECTED CUSTOMER SITES ARE BEING UPGRADED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441867 ENDOTOOL IV ENDOTOOL IV NDC MONARCH MEDICAL TECHNOLOGIES IV SOFTWARE VERSIONS 1.8.5 AND HIGHER

    Patients

    Seq Age Sex Outcome Treatment
    1