BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090076 · Received May 5, 2011

    Report

    Report Number
    2032227-2011-01160
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 27, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 FOLLOWING INFORMATION WAS REPORTED BY THE CUSTOMER'S ATTORNEY'S OFFICE: ON (B)(6) 2009, THE CUSTOMER WAS HOSPITALIZED WITH ELEVATED KETONE LEVELS ALLEGEDLY CAUSED BY ISSUES WITH AN INSULIN PUMP AND INFUSION SET. ON (B)(6) 2009, THE CUSTOMER EXPERIENCED ADDITIONAL PROBLEMS RELATED TO LOW BLOOD SUGAR LEVELS ALLEGEDLY CAUSED BY FAILURE OF THE INSULIN PUMP AND INFUSION SET. THE SYMPTOMS ALLEGEDLY CAUSED LIGHT-HEADEDNESS AND INSTABILITY THAT RESULTED IN A FALL IN WHICH CUSTOMER FRACTURED HER RIGHT LEG. 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-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization