BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM

    MDR report key: 4450615 · Received January 16, 2015

    Report

    Report Number
    MW5040349
    Event Type
    Injury
    Date Received
    January 16, 2015
    Date of Event
    June 12, 2011
    Report Date
    January 16, 2015
    Manufacturer
    MEDTRONIC
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC PARADIGM INSULIN PUMP MALFUNCTIONED ON ITS OWN, DELIVERING AN INSULIN OVERDOSE OF 20-40 UNITS TO MY (B)(6) DAUGHTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40495 PARADIGM PARADIGM OYC MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization| L| S