BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3100516 · Received May 8, 2013

    Report

    Report Number
    3004209178-2013-93213
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNIT PASSED REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM, AND DISPLACEMENT TESTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP DRIVE SUPPORT CAP IS LOOSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201496 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR