BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2103788 · Received May 18, 2011

    Report

    Report Number
    3004209178-2011-81500
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS, WITH A READING OF 380 MG/DL. THE CUSTOMER'S LAST INFUSION SET CHANGE WAS ON (B)(6) 2011. THE CUSTOMER BEGAN EXPERIENCING ELEVATED BLOOD GLUCOSE LEVELS AFTER THE INFUSION SET CHANGE. THE CUSTOMER TREATED WITH THE INSULIN PUMP AND MANUAL INJECTIONS, BUT CONTINUED EXPERIENCING HIGH BLOOD GLUCOSE LEVELS AND VOMITING. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME AND HIGH PRESSURE TESTS. NOTHING FURTHER WAS REPORTED.

    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-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization