BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3143630 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-94325
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 15, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT TEST. ALL OPERATING CURRENTS WERE WITHIN SPECIFICATION. THE DEVICE WAS PROGRAMMED AND MONITORED FOR TWO DAYS AND NO BLANK DISPLAY NOTED. THE MOTOR PASSED THE MOTOR TEST. THE INSULIN PUMP HAD SCRATCHED DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM WITH KETONES AND HIGH BLOOD GLUCOSE OF 343MG/DL. THE MOTHER STATED THAT THE CUSTOMER HAD BEEN VOMITING MOST OF THE DAY AND SHE THOUGH IT WAS FOOD POISON. LATER, SHE CHECKED THE INSULIN PUMP AND NOTICED THE DEVICE HAD BLANK DISPLAY AND ALARMED BAD BATTERY A FEW TIMES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243881 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization