BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183133 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40082
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE HOSPITAL AND HAS ASTHMA. CUSTOMER WAS PUT ON PREDNISONE AND HER SUGAR WENT UP TO 553 MG/DL. CUSTOMER WAS GIVEN A MANUAL INJECTION, BUT DOES NOT KNOW IF SHE SHOULD GIVE ANOTHER INJECTION OR USE THE PUMP. CUSTOMER WAS RUNNING HIGH WITH BLOOD GLUCOSE LEVELS OF 458 MG/DL AT 6:11 AND 473 MG/DL AT 7:00. CUSTOMER WAS ADVISED TO CONTACT THE HEALTH CARE PROFESSIONAL OR HOSPITAL TO FIND OUT WHAT SHE NEEDS TO DO TO TREAT. CUSTOMER WAS ALSO ADVISED THAT SHE CAN RUN A TEMP BASAL, BUT SHE WOULD NEED TO SPEAK WITH A HEALTH CARE PROFESSIONAL TO SEE WHAT RATES TO RUN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660577 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization