BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3261086 · Received August 2, 2013

    Report

    Report Number
    2032227-2013-03302
    Event Type
    Injury
    Date Received
    August 2, 2013
    Date of Event
    June 21, 2013
    Report Date
    July 8, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 CURRENT BLOOD GLUCOSE READING IS 246 MG/DL. THE PARAMEDICS WERE CALLED TO TREAT A HIGH BLOOD GLUCOSE READING OF OVER 700 MG/DL. CUSTOMER WAS TRANSPORTED TO HOSPITAL. DIAGNOSED DIABETIC KETOACIDOSIS. CUSTOMER FELT SICK. CUSTOMER WAS RELEASED FROM HOSPITAL AFTER THREE DAYS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361979 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization