BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2123154 · Received June 10, 2011

    Report

    Report Number
    2032227-2011-01422
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH A LOW BLOOD GLUCOSE READING OF 18 MG/DL. IT WAS STATED THAT THE CUSTOMER WAS FOUND UNRESPONSIVE BY FAMILY MEMBERS. THE CUSTOMER WAS NOT FEELING WELL ENOUGH TO TROUBLESHOOT AT THE TIME OF THE CALL. ADVISED THE NURSE TO HAVE THE CUSTOMER CALL BACK FOR TROUBLESHOOTING. 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-522RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization