BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2063121 · Received April 12, 2011

    Report

    Report Number
    3004209178-2011-81007
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 30, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 INSULIN PUMP DELIVERED INSULIN WITHOUT BEING PROGRAMMED TO DELIVER. THE CUSTOMER'S MOTHER STATED THAT THIS HAPPENED ON TWO SEPARATE OCCASIONS AND THAT THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE LEVELS AS A RESULT. THE CUSTOMER STATED THAT THE BOLUS HISTORY SHOWED TWO BOLUSES AN HOUR APART AND THAT ONLY ONE WAS PROGRAMMED. THE CUSTOMER ALSO STATED THAT SHE WAS USING THE EASY BOLUS FEATURE AND WAS NOT USING THE DUALWAVE OR SQUAREWAVE BOLUS, WHICH MIGHT HAVE EXPLAINED THE AN ADDITIONAL DELIVERY. 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-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR