BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2182513 · Received July 19, 2011

    Report

    Report Number
    3004209178-2011-82218
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    July 2, 2011
    Report Date
    July 7, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    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 REPORT BEING HOSPITALIZED DUE TO DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS OVER 600 MG/DL. THE CUSTOMER STATED THAT HE GOT HIS BRACES AND WISDOM TOOTH REMOVED AND HE HAS BEEN UNDER A LOT OF STRESS. THE CUSTOMER STATED THAT HE HAD EXPERIENCED UNEXPLAINED BLOOD GLUCOSE FOR THE PAST TWO YEARS. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 282MG/DL AND 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-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization