BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 1993491 · Received February 8, 2011

    Report

    Report Number
    3004209178-2011-80370
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 30, 2011
    Report Date
    February 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE OVER 1000MG/DL. IT WAS STATED THAT THE CUSTOMER EXPERIENCED VOMITING BILE AND BLOOD, NAUSEOUS, HIGH HEART RATE, AND HYPERTENSION. IT WAS THAT TROUBLESHOOTING WAS DECLINED AND THE FATHER REQUESTED A REPLACEMENT OF THE INSULIN PUMP. IT WAS STATED THAT THE CUSTOMER WAS TREATED WITH INSULIN DRIP. NO FURTHER INFO WAS PROVIDED.

    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-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization