BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2020695 · Received March 7, 2011

    Report

    Report Number
    3004209178-2011-80551
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS RUSHED TO THE EMERGENCY ROOM DUE TO LOW BLOOD GLUCOSE LEVELS, WITH A READING OF 22 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER WAS EXPERIENCING BLOOD GLUCOSE LEVELS OVER 400 MG/DL AT SCHOOL, POSSIBLY DUE TO A BENT CANNULA. THE SCHOOL PERFORMED TROUBLESHOOTING ON THE INSULIN PUMP, AND ACCIDENTALLY DELIVERED 35 UNITS OF INSULIN TO THE CUSTOMER, CAUSING HIS BLOOD GLUCOSE LEVELS TO DROP. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE PRIME TEST. THE FATHER FELT THAT THE INSULIN PUMP WAS FUNCTIONING PROPERLY, AND STATED THAT HE WOULD CALL BACK IF FURTHER ASSISTANCE WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Hospitalization