BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3192815 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-95116
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    July 1, 2012
    Report Date
    June 9, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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

    CUSTOMER CALLED TO REPORT A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 480 MG/DL. THE SITE CAME OUT OF LEG, CUSTOMER WAS UNAWARE THAT HE WAS NOT RECEIVING INSULIN. THE CUSTOMER ATE A HUGE LUNCH. THE BLOOD GLUCOSE INCREASED. CUSTOMER EXPERIENCE VOMITING, DIFFICULTY BREATHING AND TACHYCARDIA. DIAGNOSED WITH DIABETIC KETOACIDOSIS. CUSTOMER WAS TREATED WITH IV FLUIDS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293980 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 25 YR Hospitalization