BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2090947 · Received May 2, 2011

    Report

    Report Number
    2032227-2011-01107
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 25, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. PLEASE SEE ALSO MFR REPORT NUMBER 3004209178-2011-81296.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY CALLED TO REPORT NO RESERVOIR ALARMS. FOUND THAT THE CUSTOMER CHANGED THE INFUSION SET AND REMOVED THE ENTIRE PLUNGER FROM THE RESERVOIR, THEN INSERTED IT INTO THE INSULIN PUMP. FOUND THAT THE INSULIN LEAKED INTO THE RESERVOIR COMPARTMENT. LATER, THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS, WITH A READING OF 32 MG/DL. THE CUSTOMER FELT THAT THE INSULIN PUMP DELIVERED INSULIN WITHOUT HER PROGRAMMING IT TO DELIVER. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. 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-722RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization