BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOSTABILIZER

    MDR report key: 6906754 · Received October 2, 2017

    Report

    Report Number
    MW5072548
    Event Type
    Injury
    Date Received
    October 2, 2017
    Report Date
    September 29, 2017
    Manufacturer
    MEDICAL DECISION NETWORK
    Product Code
    NDC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE GLUCOSTABILIZER INSULIN DRIP SOFTWARE GENERATES UNSAFE DOSES WHEN HIGH GLUCOSE VALUES ARE ENTERED. AS A WORK-AROUND, THEY RECOMMEND USERS NOT TO ENTER VALUES ABOVE 500-600 MG/DL. THE PROGRAM INCREASES THE DRIP WITH EACH ADJUSTMENT REGARDLESS OF PT RESPONSE. THE DOSES WILL ALWAYS BE 8.8, 13.2, AND 17.6 UNITS/HR WHEN AN ARBITRARY VALUE OF "500" IS ENTERED, AND DOSES OF 10.8, 16.2, AND 21.6 WHEN A VALUE OF "600" IS ENTERED. THIS HAS REPEATEDLY RESULTED IN VERY RAPID GLUCOSE CHANGES. MANY CASES OF OVERLY RAPID CORRECTION (GOAL APPROX 100MG/DL/HR). WE HAVE NOTICED VERY RAPID DECLINES IN POTASSIUM WHICH AFFECT THE HEART, HEADACHE, AND NAUSEA/VOMITING, AND DECREASED LOC TO WHICH THIS MAY HAVE CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686393 GLUCOSTABILIZER INSULIN DRIP TITRATION SOFTWARE NDC MEDICAL DECISION NETWORK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| O| R