BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2253924 · Received September 13, 2011

    Report

    Report Number
    2032227-2011-02291
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    August 20, 2011
    Report Date
    August 29, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR ASSISTANCE WITH THE FIXED PRIME. THE CUSTOMER IS BLIND, AND STATED THAT IT WAS SET TO 10.0. THE CUSTOMER CHANGED THE INFUSION SET AND RAN A FIXED PRIME. A COUPLE OF HOURS LATER HE WAS UNCONSCIOUS, AND WAS BEING TREATED BY THE PARAMEDICS DUE TO A LOW BLOOD GLUCOSE READING OF 21 MG/DL. THE CUSTOMER WAS ASSISTED IN SETTING THE FIXED PRIME BACK TO 0.3. 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-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention