BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3180930 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-94886
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE OF 400MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE TIME AND DATE WERE INCORRECT, AND THE CUSTOMER WAS ASSISTED TO CORRECT THEM. INSTRUCTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. AFTER RECEIVING THE TUBING CLAMP THE CUSTOMER CALLED BACK TO PERFORM THE HIGH PRESSURE TEST AND PASSED. SUGGESTED THE CALLER TO REMOVE THE CANNULA AND IT WAS NOT BENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279745 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 53 YR Hospitalization