BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2040066 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-80808
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    January 12, 2011
    Report Date
    March 21, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A FROZEN DISPLAY, FOLLOWED BY A CONSTANT TONE. THE PROBLEM HAS BEEN ISOLATED TO THE MOTHERBOARD, BUT AS A RESULT, WE ARE UNABLE TO VERIFY THE BUTTON KEYPAD ANOMALY AND CONSTANT TONE. NO UNEXPECTED CONSTANT BACKLIGHT WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE INSULIN PUMP WAS GIVING ONE CONSTANT TONE WITH THE BACKLIGHT ON. THE CUSTOMER STATED THAT THE INSULIN PUMP IS IN ALARM MODE AND NONE OF THE BUTTONS WERE RESPONDING. THE CUSTOMER ALSO STATED THAT AFTER THE BATTERY WAS REMOVED AND REINSERTED, THE INSULIN PUMP CAME BACK ON WITH THE BACK LIGHT OFF BUT THE BUTTONS REMAINED UNRESPONSIVE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR