BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2113504 · Received May 24, 2011

    Report

    Report Number
    3004209178-2011-81572
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 19, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP HAD OVER-DELIVERED INSULIN. THE CUSTOMER'S FATHER STATED THAT THE INSULIN PUMP'S HISTORY FILE SHOWED DELIVERIES THAT HAD NOT BEEN PROGRAMMED. THE CUSTOMER'S FATHER STATED THAT AS A RESULT, THE CUSTOMER HAD EXPERIENCED SEVERAL EPISODES OF LOW BLOOD GLUCOSE LEVELS OVER THE PERIOD OF SEVERAL DAYS, INCLUDING WHILE THE CUSTOMER WAS SITTING IN CLASS. THE CUSTOMER'S FATHER THEN STATED THAT PARAMEDICS HAD BEEN CONTACTED. 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-554WWB

    Patients

    Seq Age Sex Outcome Treatment
    1