BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4705879 · Received April 20, 2015

    Report

    Report Number
    3004209178-2015-49771
    Event Type
    Injury
    Date Received
    April 20, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 1, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A HIGH BLOOD GLUCOSE BUT NOT HOSPITALIZED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 326 MG/DL. THE CUSTOMER WILL NEED TO CHANGE OUE HER SET. THE CUSTOMER WAS ASK TO BOLUS AND SEE IF SHE GETS ANOTHER NO DELIVERY. THE CUSTOMER STATED THAT IT IS WORKING FINE NOW. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260943 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR