BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2202309 · Received August 2, 2011

    Report

    Report Number
    3004209178-2011-82400
    Event Type
    Injury
    Date Received
    August 2, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 HIGH BLOOD GLUCOSE OF 1910MG/DL. IT WAS STATED THAT THE CUSTOMER TREATED HIS HIGH BLOOD GLUCOSE OF 400 MG/DL WITH 15.0 UNITS OF INSULIN AND A FEW HOURS LATER, HIS GLUCOSE LEVEL INCREASED TO MORE THAN 700MG/DL. IT WAS STATED THAT THE CUSTOMER DISCONNECTED THE INSULIN PUMP AND WENT TO THE HOSPITAL. THE NURSE STATED THAT THE CUSTOMER WAS SLEEPING AT THE TIME OF CALL AND HIS BLOOD GLUCOSE WAS TREATED WITH THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization