BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3930891 · Received July 12, 2014

    Report

    Report Number
    3004209178-2014-86872
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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 WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM DURING TESTING. NO UNEXPECTED NUMBERS SCROLLING DURING TESTING. CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESRVOIR TUBE LIP, MINOR SCRATCHED LCD WINDOW, MISSING END CAP STICKER AND CRACKED BATTERY TUBE THREADS NOTED.

    Description of Event or Problem · 1

    CUSTOMER CALLED STATING THAT HER INSULIN PUMP IS ALARMING BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 145 MG/DL. SHE SAID THAT WHEN SHE TRIED TO BOLUS, THE NUMBERS ON THE SCREEN STARTED TO SCROLL UP ON ITS OWN. SHE CHANGED THE BATTERY AND THE DEVICE ALARMED BUTTON ERROR. THE BUTTONS ARE NOT RESPONDING. CUSTOMER STATED THAT THE DEVICE WAS NOT EXPOSED TO MOISTURE. CUSTOMER WAS ADVISED THAT THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE ITS USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408437 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR