BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2123137 · Received June 10, 2011

    Report

    Report Number
    2032227-2011-01415
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS, VOMITING AND DIARRHEA. THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE OVER 600 MG/DL. THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS FOR THE PAST 16 DAYS. TROUBLESHOOTING WAS NOT POSSIBLE AS THE INSULIN PUMP HAD NO POWER, AND THE BATTERY CAP COULD NOT BE REMOVED. 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-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization UNOMEDICAL QUICK-SET PARADIGM INFUSION SET,MMT-397