BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2990688 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-91626
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 23, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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

    THE CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OVER 500MG/DL. THE CUSTOMER EXPERIENCED THIRSTY, DRIED THROAT, SORE GUMS, VOMITING, AND CRAMPS. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER MENTIONED THAT THE INSULIN PUMP ALARMED NO DELIVERY OVER THE LAST TWENTY FOUR HOURS. THE CALLER STATED THAT HE WAS INSTRUCTED TO TAKE OFF THE DEVICE WHEN THEY BEGAN TO TREAT HIM WITH AND INSULIN DRIP AND FLUIDS. TROUBLESHOOTING WAS PERFORMED. ASSISTED THE CUSTOMER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. THE DRIVE SUPPORT CAP WAS NORMAL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94345 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization