BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2133692 · Received June 9, 2011

    Report

    Report Number
    2032227-2011-01402
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 STATED THAT THE PARAMEDICS WERE CALLED TO HER HOME THIS MORNING DUE TO HIGH BLOOD GLUCOSE LEVELS. WHEN THE CUSTOMER WOKE UP, HER BLOOD GLUCOSE WAS 568 MG/DL, THEN WENT OUT OF RANGE. THE CUSTOMER CHANGED THE INFUSION SET THE NIGHT BEFORE, AND FELT LIKE IT DIDN'T INSERT PROPERLY. WHEN SHE REMOVED IT, THE CANNULA WAS BENT. THE CUSTOMER CHANGED THE INFUSION SET, AND HER BLOOD GLUCOSE LEVELS STARTED GOING BACK DOWN. 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-722RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention