BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3941759 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87476
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL BUTTONS FUNCTION PROPERLY. HOWEVER, MOISTURE DAMAGE WAS FOUND ON KEYPAD TRACES. NO BUTTON ERROR ALARM NOTED DURING TESTING. ALL OPERATING CURRENTS ARE WITHIN THE SPECIFICATION, NO UNEXPECTED LOW BATTERY, OFF/NO POWER OR BATTERY OUT OF LIMIT ALARM NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, BROKEN INSULIN PUMP BELT CLIP SLOT AND CRACKED LCD WINDOW.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS ALARMING BATTERY OUT LIMIT. CUSTOMER STATED THAT THE DEVICE BEGAN ALARMING IN THE MORNING AND EVEN AFTER CHANGING THE BATTERIES, THE DEVICE CONTINUED TO ALARM. CUSTOMER WAS UNSURE IF THERE MAY HAVE ALSO BEEN A BUTTON ERROR ALARM AS THE KEYPAD IS ALSO UNRESPONSIVE TO USER INPUT. CUSTOMER STATED THEY DO NOT RECALL ANY SIGNIFICANT EVENTS THAT LEAD TO THE ALARM OR IF THE DEVICE WAS DROPPED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 120 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419464 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR