BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2032349 · Received March 22, 2011

    Report

    Report Number
    3004209178-2011-80747
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 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
    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 THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE CUSTOMER'S MOTHER STATED THAT PRIOR TO THE EVENT, THE CUSTOMER HAD BEEN OFF THE INSULIN PUMP FOR A PERIOD OF TIME BUT HAD RECENTLY STARTED USING IT AGAIN. THE CUSTOMER'S MOTHER STATED THAT THE DOCTORS BELIEVE THAT THE INSULIN WAS BAD, SINCE THERE WERE NO INDICATIONS THAT THE PROBLEM WAS WITH THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722CAL

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization