BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2914259 · Received January 14, 2013

    Report

    Report Number
    2032227-2012-08081
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 1, 2012
    Report Date
    March 17, 2024
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21721 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-523RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female