BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3943048 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87705
    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
    OK
    Reporter Occupation
    PATIENT

    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

    THE INSULIN PUMP RECEIVED WITH CURRENTS IN SPECIFICATION. NO BLANK DISPLAY. LCD BOARD OK. NO BUTTON ERROR ALARM. INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE TO KEYPAD TRACE. THE INSULIN PUMP HAS CRACKED DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER CALLED STATING SHE HAS A BLANK SCREEN ON HER INSULIN PUMP. IT HAPPENED THREE TIMES TODAY DURING TRAINING. THE TRAINER ADVISED HER TO CALL THE HELP LINE. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 313 MG/DL. SHE HAS TREATED WITH THE DEVICE AND FEELS FINE. THE DEVICE IS NOT DAMAGED. IT WAS NOT BUMPED OR DROPPED. THERE WAS NO MOISTURE EXPOSURE. CUSTOMER IS USING AN ENERGIZER BATTERY. THE BATTERY COMPARTMENT, BATTERY CAP, AND SPRING IS NOT DAMAGED OR CORRODED. CUSTOMER INSERTED A NEW BATTERY AND THE DEVICE ALARMED BUTTON ERROR. CUSTOMER WAS ADVISED THAT THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419947 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR