BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3984501 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-90347
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH CURRENTS IN SPECIFICATION. NO UNEXPECTED FAILED BATTERY TEST OR BATTERY OUT OF LIMIT. INSULIN PUMP HAD AN INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE KEYPAD TRACE. INSULIN PUMP HAD MINOR SCRATCHES ON LCD WINDOW, CRACKED DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS CRACKED, BROKEN BELT CLIP SLOT AND CRACKED RESERVOIR TUBE LIP. NUMBERS DO NOT RAMP UP ON OR SCROLL BAR MOVING WITH NO INPUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD OF THE INSULIN PUMP WAS UNRESPONSIVE. WHILE PROGRAMMING A BOLUS THE NUMBERS KEPT SCROLLING. THE CUSTOMER REMOVED THE BATTERY AND THE INSULIN PUMP ALARMED FAILED BATTERY. THE CUSTOMER CLEARED THE ALARM AND PLACED A NEW BATTERY, BUT THE BUTTONS WERE STILL UNRESPONSIVE AND THE DEVICE ALARMED ANOTHER ERROR. THE CUSTOMER'S BLOOD GLUCOSE WAS 203 MG/DL. THE DISCONTINUATION OF THE INSULIN PUMP WAS ADVISED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459772 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR