BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974653 · Received August 3, 2014

    Report

    Report Number
    2032227-2014-05244
    Event Type
    Malfunction
    Date Received
    August 3, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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

    CUSTOMER REPORTS THAT THE AUTO OFF FEATURE WAS ACTIVATED ON HER INSULIN PUMP AND THE FLOW OF INSULIN WAS STOPPED. THE CUSTOMER BLOOD GLUCOSE WAS NOT PROVIDED. CUSTOMER WAS ADVISED ON HOW TO TURN THE FEATURE OFF ON HIS INSULIN PUMP. THE CALL THEN BECAME DISCONNECTED AND ATTEMPTED TO CONTACT CUSTOMER BUT IT WENT STRAIGHT TO VOICE MAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452403 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR