BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3900838 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-85279
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 8, 2014
    Report Date
    August 28, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.MED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378581 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO.MED MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male Hospitalization| R FRN-UNK-RSVR, UNOMED INF SET.