BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2142386 · Received June 21, 2011

    Report

    Report Number
    2032227-2011-01540
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 9, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 2032227-2011-01539.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO LOW BLOOD GLUCOSE LEVELS. PER THE CUSTOMER'S DOCTOR, THE EVENT WAS DUE TO EXCITEMENT AND EXCESSIVE HEAT FROM BEING AT A CONCERT. PRIOR TO BEING ADMITTED, THE CUSTOMER PASSED OUT AND WAS TREATED BY THE PARAMEDICS. THE CUSTOMER'S LAST INFUSION SET CHANGE WAS THREE DAYS PRIOR TO THE EVENT, AND SHE WAS NOT CONNECTED TO THE INFUSION SET DURING THE REWIND OR PRIME. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. 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 19 YR Hospitalization