BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3182756 · Received June 21, 2013

    Report

    Report Number
    2032227-2013-02521
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 30, 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 FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 970 MG/DL. CUSTOMER WAS NOT FEELING WELL, NAUSEA AND VOMITING. DIAGNOSED WITH DIABETIC KETOACIDOSIS. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 55 MG/DL. TREATED WITH JUICE. DURING TROUBLESHOOTING, TIME AND DATE ARE CORRECT. PROGRAMMING IS CORRECT. MANUAL PRIME IS CORRECT, INSULIN EXITED THE INSULIN PUMP. HIGH PRESSURE TEST PASSED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283607 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization