BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3854987 · Received June 9, 2014

    Report

    Report Number
    2032227-2014-02958
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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 WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH INSULIN DRIP. PRIOR TO THE EVENT, THE CUSTOMER WAS ALREADY AT THE HOSPITAL TO HAVE A HEART PROCEDURE. THE PHYSICIAN WAS UNABLE TO CONTINUE WITH THE PROCEDURE BECAUSE THE PATIENT'S BLOOD GLUCOSE LEVEL WAS TOO HIGH. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 814 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335728 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization