BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2142316 · Received June 20, 2011

    Report

    Report Number
    2032227-2011-01508
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    March 15, 2011
    Report Date
    June 4, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 BLOOD GLUCOSE LEVELS OVER 450 MG/DL. UNABLE TO TROUBLESHOOT AT THE TIME OF THE CALL AS THE INSULIN PUMP HAD ALREADY BEEN REPLACED. THE CUSTOMER STATED THAT HER INFUSION SET WAS REMOVED AT THE HOSPITAL, AND THE TAPE WAS INTACT, BUT THE CANNULA HAD BECOME DISLODGED. THE CUSTOMER STATED THAT SHE WAS DOING YARD WORK THAT DAY, AND FELT THAT THE CANNULA BECAME DISLODGED WHEN SHE PICKED UP A HEAVY BAG OF MULCH. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization