BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972078 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05090
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 10, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER'S INSULIN PUMP WILL PUSH OUT INSULIN AND WOULD NOT STOP. CUSTOMER'S FATHER TRIED TO PRIME AND THE EVEN REOCCURRED. CUSTOMER'S FATHER WANTED TO JUST CHANGE THE DEVICE WITHOUT CONDUCTING TROUBLESHOOTING. FATHER STATED HE DID NOT FEEL SAFE WITH THE DEVICE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447279 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR