BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2190306 · Received July 19, 2011

    Report

    Report Number
    2032227-2011-01771
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    May 1, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 REPORTED THAT SHE WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS, WITH BLOOD GLUCOSE LEVELS BETWEEN 300 AND 500 MG/DL. THE CUSTOMER STATED THAT SHE WAS GOING IN AND OUT OF CONSCIOUSNESS, AND HER DAUGHTER CALLED THE PARAMEDICS FOR HER. THE CUSTOMER FELT THAT STRESS, AS WELL AS HER INSULIN SENSITIVITY MAY HAVE CONTRIBUTED TO THE EVENT. 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 MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization