BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2943658 · Received February 5, 2013

    Report

    Report Number
    2032227-2013-00341
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 10, 2013
    Report Date
    March 18, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49533 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female Hospitalization UNOMEDICAL INSULIN INFUSION SET