BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED® 630G

    MDR report key: 6672727 · Received June 28, 2017

    Report

    Report Number
    6672727
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    June 21, 2017
    Report Date
    June 22, 2017
    Manufacturer
    MEDTRONIC MINIMED, INC.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS BEING INSTRUCTED ON THE USE OF THEIR INSULIN PUMP BY THE DIABETES EDUCATOR. AFTER INSERTING THE INFUSION SET CATHETER, THE PATIENT COMPLAINED OF PAIN AND THE CATHETER SITE WAS REMOVED. UPON REMOVAL THE NURSE NOTICED THAT THE SITE WAS WET WITH INSULIN AND SO WAS THE CATHETER. THE NURSE INFORMED ME THE ENTIRE RESERVOIR HAD EMPTIED. THE PATIENT'S BLOOD GLUCOSE WAS CHECKED AND THEN THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT DUE TO THE RISK OF A SERIOUS HYPOGLYCEMIC EVENT. THE INCIDENT WAS REPORTED TO MEDTRONIC AND THE PATIENT WILL BE RETURNING THE INSULIN PUMP TO THE MANUFACTURER. THE PATIENT WILL BE RETURNING THE PUMP, PUMP RESERVOIR, AND INFUSION SET TO MEDTRONIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455365 MINIMED® 630G INSULIN PUMP LZG MEDTRONIC MINIMED, INC. 630G

    Patients

    Seq Age Sex Outcome Treatment
    1