BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2190331 · Received July 20, 2011

    Report

    Report Number
    3004209178-2011-82242
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 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
    IT
    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 HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. IT WAS STATED THAT WHILE THE CUSTOMER WAS RIDING A BICYCLE WITH THE INSULIN PUMP IN THE POCKET, THE INSULIN PUMP DELIVERED A 25.0 UNITS BOLUS. IT WAS STATED THAT AFTER RECEIVING THE INSULIN THE PT WENT TO SLEEP, AND THE CUSTOMER WAS FOUND IN COMA DURING THE NIGHT. THE CUSTOMER WAS RUSHED TO THE HOSPITAL TO BE TREATED PROPERLY. 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-522WWB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization