BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDOTOOL DRUG DOSE CALCULATOR

    MDR report key: 1188464 · Received September 29, 2008

    Report

    Report Number
    3005214420-2008-00001
    Event Type
    Other
    Date Received
    September 29, 2008
    Date of Event
    February 22, 2008
    Report Date
    February 24, 2008
    Manufacturer
    MD SCIENTIFIC
    Product Code
    NDC
    PMA / PMN Number
    K053137
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 TPN AND AN UNSPECIFIED CONTINUOUS INFUSION CONTAINING D5W. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE BEING MONITORED USING THE ENDOTOOL. THE CUSTOMER CONTACT REPORTED THAT THE NURSE FELT THAT THE GLUCOSE LEVELS WERE REMAINING HIGHER THAN INTENDED. IT WAS REPORTED THAT 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. NO MEDICAL INTERVENTIONS WERE REPORTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. 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 33 YR Other