BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2072797 · Received March 31, 2011

    Report

    Report Number
    3004209178-2011-80894
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 21, 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
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP MOTOR WAS SEATED IN THE BEGINNING OF THE DISPLACEMENT TEST DUE TO A LOOSE MOTOR SUPPORT DISK. AS A RESULT, WE WERE UNABLE TO PERFORM THE DISPLACEMENT TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A NO DELIVERY ALARM ON THE INSULIN PUMP. THE CUSTOMER'S MOTHER STATED THAT SHE IS HAVING A HARD TIME PRIMING THE INSULIN PUMP AFTER THE ALARM WAS CLEARED. TROUBLESHOOTING WAS PERFORMED. NUMBERS STARTED RAMPING UP ON THE INSULIN PUMP WHILE IT WAS COMPLETELY EMPTY AND THE INSULIN PUMP FAILED THE DISPLACEMENT TEST. 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-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR