BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3041713 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-92434
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. THE MOTHER STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY WHEN THE CUSTOMER ATTEMPTED TO GIVE A BOLUS. ADVISED THE CALLER TO DISCONNECT AT THE QUICK RELEASE AND VERIFIED IF THERE IS NO AIR IN THE TUBING. THE MOTHER STATED THAT THE INSULIN DID EXIT. THE CALLER MENTIONED THAT THE CUSTOMER ATTEMPTED TO GIVE 3.7 UNITS OF INSULIN BEFORE CALLING, BUT THE DEVICE STOPPED AT 1.1UNITS, AND ONCE THE INSULIN FLOWED THROUGH THE TUBING, THE CUSTOMER GAVE THE DIFFERENCE AND DELIVERED WITHOUT ALARMING NO DELIVERY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143103 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization