BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDOTOOL DRUG DOSE CALCULATOR

    MDR report key: 1188465 · Received September 29, 2008

    Report

    Report Number
    3005214420-2008-00003
    Event Type
    Other
    Date Received
    September 29, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    MD SCIENTIFIC
    Product Code
    NDC
    PMA / PMN Number
    K053137
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CUSTOMER CONTACT REPORTED THAT THE EVENT WAS USER ERROR BY THE OPERATOR.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A USER ERROR BY THE OPERATOR RESULTING IN THE PATIENT HAVING HIGHER BLOOD GLUCOSE LEVELS THAN INTENDED. THE PATIENT WAS RECEIVING A CONTINUOUS INFUSION OF D5 1/2 NS AT AN UNSPECIFIED RATE. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE BEING MONITORED USING THE ENDOTOOL. IT WAS REPORTED THAT EVERY HOUR FOR SEVEN HOURS AFTER THE D5 1/2 NS INFUSION WAS STARTED, THE NURSE WAS INCORRECTLY SELECTING THE "EXTRA CALORIES" BUTTON WHEN ENTERING DATA INTO THE DEVICE. THE NURSE WAS RE-EDUCATED ON THE FUNCTION OF THE "EXTRA CALORIES" BUTTON AND THE D5 1/2 NS INFUSION WAS STOPPED. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTOOL DRUG DOSE CALCULATOR NDC MD SCIENTIFIC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other