BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARDIGM INSULIN PUMP AND QUICKSET PARADIGM

    MDR report key: 3231333 · Received July 12, 2013

    Report

    Report Number
    MW5030903
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    May 18, 2013
    Report Date
    July 8, 2013
    Manufacturer
    MEDTRONIC MINI-MED
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WAS GOLFING WITH MY SON WHEN I STARTED TO NOTICE MY BLOOD SUGAR WAS PROBABLY ELEVATED. TOOK A CORRECTION BOLUS FROM MY INSULIN PUMP. REPEATED THAT A COUPLE OF TIMES. RECEIVED NO WARNING THAT I WAS NOT GETTING INSULIN. CHECKED BLOOD GLUCOSE LEVEL AT HOME AND IT WAS GREATER THAN 600. WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED IN ICU FOR 3 DAYS. BLOOD GLUCOSE LEVEL OVER 600 CAUSING KETOACIDOSIS, RENAL FAILURE, ACUTE MI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322213 PARDIGM INSULIN PUMP AND QUICKSET PARADIGM PARDIGM INSULIN PUMP AND QUICKSET PARADIGM FRN MEDTRONIC MINI-MED 722

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| O| R CALCIUM-VITAMIN D| CLOPIDOGREL| INSULIN| ASPIRIN| ISOSORBIDE MONONITRATE| NITROGLYCERIN| CICLOPIROX *% SOLUTION| PRAMPIPEXOLE| VITAMIN D| ATORVASTATIN| INSULIN PUMP| RAMIPRIL| TEMAZEPAM| LYRICA