BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4153729 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-24908
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A NO DELIVERY ALARM ON THE INSULIN PUMP DURING BASAL DELIVERY, WHILE IT WAS DISCONNECTED FROM THE SITE. THE CUSTOMER CONFIRMED SEEING DROPS AT THE END OF THE TUBING DURING PRIME. THE CUSTOMER WAS INSTRUCTED TO REMOVE THE RESERVOIR AND MANUALLY PUSH INSULIN THROUGH AND THERE WAS NO RESISTANCE. THE CUSTOMER WAS INSTRUCTED TO REWIND AND PRIME AND RAN A FIVE UNIT FILL CANNULA SUCCESSFULLY. THE CUSTOMER REMOVED THE INFUSION SET AND IT WAS FOUND THAT THE CANNULA WAS BENT. THE CUSTOMER'S BLOOD GLUCOSE WAS NOT KNOWN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632135 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CML

    Patients

    Seq Age Sex Outcome Treatment
    1