BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3933432 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-87057
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CHANGING HER INFUSION SET. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 96 MG/DL. THE ALARM WAS CLEARED WITH THE ESC AND ACT BUTTONS. THE CONNECTION WAS CHECKED. INSULIN EXITED THE TUBING WHEN MANUALLY PUSHED. THE DEVICE WAS REWOUND AND A MANUAL PRIME WAS RUN. THE DEVICE DID NOT ALARM NO DELIVERY. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP IS WORKING AS DESIGNED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411120 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR