BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2032351 · Received March 22, 2011

    Report

    Report Number
    3004209178-2011-80753
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 9, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO KETONES AND HIGH BLOOD GLUCOSE LEVELS OVER 600 MG/DL. THE CUSTOMER'S FATHER STATED THAT PRIOR TO THE EVENT, THE CUSTOMER HAD BEEN HAVING HIGH KETONES AND ELEVATED BLOOD GLUCOSE LEVELS. THE CUSTOMER'S FATHER ALSO STATED THAT AFTER THE FIRST HIGH KETONE READING, HE DISCONNECTED THE CUSTOMER FROM THE INSULIN PUMP. THE CUSTOMER IS USING A QUICK-SET INSULIN INFUSION SET. PROGRAMMING WAS CORRECT AND TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE FIXED PRIME AND THE HIGH PRESSURE TEST. 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 PUERTO RICO OPERATIONS MED-REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization UNOMEDICAL QUICK-SET INSULIN INFUSION SET