BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3191789 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-95079
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    April 9, 2013
    Report Date
    June 11, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH A FROZEN DISPLAY AS A RESULT OF A FAULTY COMPONENT ON THE MOTHERBOARD. THE KEYPAD FUNCTIONS PROPERLY WITH TESTING ELECTRONIC UNIT. NO DAMAGE FOUND ON THE KEYPAD TRACE. 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 DISPLAY WAS SHOWING THE NUMBER FIVE, AND IT COULD NOT BE CLEARED BECAUSE THE BUTTON WAS UNRESPONSIVE. IT WAS STATED THAT THE BUTTON WAS NOT PUSHED LONGER THAN THREE MINUTES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290982 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-554WWL

    Patients

    Seq Age Sex Outcome Treatment
    1