BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4130557 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-95989
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT ALL THE BUTTONS ON THE INSULIN PUMP FUNCTIONING PROPERLY. NO UNLOCKED KEYPAD CONNECTOR NOTED DURING VISUAL INSPECTION. THE DEVICE WAS RECEIVED WITH SCRATCHED LCD WINDOW.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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

    CUSTOMER'S FATHER CALLED STATING CUSTOMER IS NOT ALWAYS ABLE TO LOCK KEYPAD ON INSULIN PUMP. CUSTOMER WAS AWAY FOR THE HOLIDAYS, AND STATES WILL CALL BACK FOR REPLACEMENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608727 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-554WWS

    Patients

    Seq Age Sex Outcome Treatment
    1