BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTOOL DRUG DOSE CALCUATOR

    MDR report key: 1236146 · Received October 24, 2008

    Report

    Report Number
    3005214420-2008-00004
    Event Type
    Malfunction
    Date Received
    October 24, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    MD SCIENTIFIC
    Product Code
    NDC
    PMA / PMN Number
    K053137
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL; HOWEVER, AN INVESTIGATION IS IN PROGRESS, BUT NOT YET COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT HAD HIGHER BLOOD GLUCOSE LEVELS THAN INTENDED. IT WAS REPORTED THAT THE PT WAS HYPERGLYCEMIC AND WAS PLACED ON ENDOTOOL FOR GLUCOSE MANAGEMENT. SPECIFIC BLOOD GLUCOSE LEVELS WERE NOT REPORTED. THE PT HAS REPORTEDLY BEEN ON ENDOTOOL FOR APPROX 10 HOURS, AND RECOMMENDATIONS FOR DOSING WERE 0 UNITS OF INSULIN WITH REPEAT BLOOD GLUCOSE LEVELS EVERY HOUR. AT AN UNSPECIFIED TIME, IT WAS NOTED THAT THE BR AND F VALUES IN ENDOTOOL WERE READING 0. THE PT'S DATA WAS RE-ENTERED INTO ENDOTOOL, AND INSULIN DOSING WAS THEN BEING RECOMMENDED AS EXPECTED, WITH CONTROL OF THE PT'S GLUCOSE LEVEL THEN BEING ACHIEVED. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other