BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3112601 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-93476
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    March 24, 2013
    Report Date
    March 24, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER, LOW BATTERY OR FAILED BATTERY TEST ALARM NOTED. THE INSULIN PUMP PASSED DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TESTS. THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON KEYPAD TRACES. NO NUMBERS RAMPING OR SCROLL BARS MOVING UP NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP IS SCROLLING ON IT'S OWN. CUSTOMER CHANGED THE BATTERY AND RECEIVED THE FAILED BATTERY TEST. CUSTOMER'S BLOOD GLUCOSE READING IS 405 MG/DL. CUSTOMER HAS TREATED WITH A MANUAL INJECTION. THE INSULIN PUMP OVER DELIVERED INSULIN AND HE WENT LOW. CUSTOMER'S BLOOD GLUCOSE DROPPED TO 36 MG/DL. CUSTOMER HAS BROUGHT UP THE BLOOD GLUCOSE LEVEL, NOW HE IS NAUSEATED AND VOMITING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213324 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR