BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOSTABILIZER

    MDR report key: 6906752 · Received October 2, 2017

    Report

    Report Number
    MW5072547
    Event Type
    Injury
    Date Received
    October 2, 2017
    Report Date
    September 29, 2017
    Manufacturer
    MEDICAL DECISION NETWORK
    Product Code
    NDC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GLUCOSTABILIZER PRODUCES EXTREMELY HIGH DOSES WHEN ACCURATE GLUCOSE LEVELS ARE ENTERED. WORK AROUND IN INSTRUCTIONS TO NOT ENTER DOSES OVER 500-600, BUT STAFF ENTERED ACCURATE DOSE, RESULTING IN DRIP RATE OVER 17 UNITS/HR. THERE SHOULD BE A SAFEGUARD IN THE PROGRAM SO ACCURATE PT INFO DOESN'T RESULT IN UNSAFE DOSE ERRORS. WE HAVE SEEN THIS PROBLEM REPEATEDLY, WHICH CAN RESULT IN UNSAFE RATES OF DECLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686392 GLUCOSTABILIZER INSULIN DRIP TITRATION SOFTWARE NDC MEDICAL DECISION NETWORK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention