BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC INSULIN PUMP

    MDR report key: 6102142 · Received November 11, 2016

    Report

    Report Number
    MW5066013
    Event Type
    Death
    Date Received
    November 11, 2016
    Date of Event
    November 6, 2016
    Report Date
    November 10, 2016
    Manufacturer
    MEDTRONIC
    Product Code
    OZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT WAS PLACED ON MEDTRONIC INSULIN PUMP ON (B)(6) 2016. EDUCATION GIVEN BY MFR REP TO PT. ON (B)(6) 2016, THE PT'S MOTHER CONTACTED THE MFR REP WITH REPORTS OF LOW BLOOD SUGAR. INSTRUCTIONS GIVEN TO CHANGE INSULIN BASAL RATE AND CARB RATIO. SETTINGS REVIEWED AND READ BACK CORRECT NEW SETTINGS. ON (B)(6) 2016, ANOTHER CALL TO REPORT LOW BLOOD SUGAR WAS PLACED BY THE PT'S MOTHER TO THE MFR REP. A BASAL RATE CHANGE WAS MADE WITH READ BACK OF THE CORRECT ADJUSTED SETTINGS. OTHER INSTRUCTIONS GIVEN FOR PROPER MANAGEMENT OF FOOD INTAKE REQUIREMENTS BASED UPON BLOOD SUGAR READINGS. ON NOVEMBER 7, 2016, THE MFR REP CONTACTED THE PT'S MOTHER AND WAS INFORMED THAT THE PT HAD PASSED AWAY ON (B)(6) 2016 IN HER SLEEP. IT WAS STATED THAT THE PT HAD REPORTED A LOW BLOOD SUGAR AT SOME POINT PRIOR TO GOING TO SLEEP THAT NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748129 MEDTRONIC INSULIN PUMP INSULIN PUMP OZO MEDTRONIC 630G

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death