BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2182446 · Received July 19, 2011

    Report

    Report Number
    3004209178-2011-82207
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 SUN GOT IN THE INSULIN PUMP AND WANTS TO BE SURE THE DEVICE WAS FUNCTIONING PROPERLY. IT WAS STATED THAT THE SETTINGS WERE REVIEWED AND APPEARS TO BE WORKING AS IT SHOULD. RAN A SELF TEST AND PASSED. DURING THE CALL, IT WAS ALSO REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. IT WAS STATED THAT THE CUSTOMER WAS NOT USING THE INSULIN PUMP AT TIME OF CALL. 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 38 YR Hospitalization