BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDOTOOL DRUG DOSE CALCULATOR

    MDR report key: 1290924 · Received December 5, 2008

    Report

    Report Number
    3005214420-2008-00007
    Event Type
    Other
    Date Received
    December 5, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    MD SCIENTIFIC
    Product Code
    NDC
    PMA / PMN Number
    K053137
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A USE ERROR BY THE OPERATOR RESULTING IN INCORRECT CALCULATION OF DOSING RECOMMENDATIONS. THE PT'S BLOOD GLUCOSE LEVELS WERE BEING MONITORED USING THE ENDOTOOL. THE CUSTOMER CONTACT REPORTED THAT THE NURSE ENTERED AN INCORRECT GLUCOSE LEVEL INTO THE ENDOTOOL AND DOSING WAS CALCULATED USING THIS INCORRECT VALUE. THE ERROR WAS NOTED 9 HOURS AFTER THE ENTRY WAS MADE; THEREFORE, DOSING WAS CALCULATED AND INSULIN WAS ADMINISTERED BASED ON AN INCORRECT VALUE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. 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 UNK