BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3123033 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-93805
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A PROTRUDED/LOOSE DRIVE SUPPORT DISK.

    Description of Event or Problem · 1

    CUSTOMER'S PARENTS CALLED TO REPORT A PROTRUDING DRIVE SUPPORT CAP. THE FIELD NOTIFICATION LETTER WAS RECEIVED AND THE PROBLEM WITH THE DRIVE SUPPORT CAP WAS IDENTIFIED. ADVISED CALLERS THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224698 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR