BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4191267 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41536
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE HOSPITAL. INFORMATION WAS REQUESTED IN REGARDS TO HOW MUCH INSULIN WAS BEING DELIVERED TO THE PATIENT AND HOW IT WAS WORKING. ASSISTANCE WAS PROVIDED TO REVIEW BASAL AND BOLUS HISTORY. ASSISTANCE WAS ALSO PROVIDED ON REMOVING THE BATTERY. IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO A BLOOD GLUCOSE IN THE 200 MG/DL TO 299 MG/DL RANGE, WHICH DROPPED TO 64 MG/DL IN A SHORT AMOUNT OF TIME. NO FURTHER DETAILS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669154 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization