BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4212126 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-44878
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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 TO HAVE RECEIVED A SIGNAL TOO LOW ALARM, AND THEN RECEIVED AN UNEXPECTED RESTART ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 134 MG/DL. CUSTOMER STATES BLOOD GLUCOSE HAD BEEN CLOSE TO 300 MG/DL, DUE TO CUSTOMER RECEIVING CORTISONE SHOTS. CUSTOMER TREATED BLOOD GLUCOSE WITH MANUAL INJECTION. CUSTOMER WAS ADVISED TO MONITOR INSULIN PUMP. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694154 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR