BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3243815 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-96010
    Event Type
    Death
    Date Received
    July 23, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 PASSED AWAY WHILE WEARING THE INSULIN PUMP. IT WAS STATED THAT THE CUSTOMER WAS TAKEN TO THE HOSPITAL DUE TO GASTRITIS. THE CUSTOMER WAS GIVEN MEDICATIONS TO HELP WITH SYMPTOMS OF PERSISTENT NAUSEA OVER A FEW WEEKS. IT WAS STATED THAT THE CUSTOMER'S BLOOD GLUCOSE READING WAS 62MG/DL WHEN SHE WAS RELEASED FROM THE HOSPITAL. HOWEVER, HER DAUGHTER TESTED AND IT WAS 531MG/DL. NINETY MINUTES LATER THE CUSTOMER WAS IN THE BED UNRESPONSIVE. THE CUSTOMER HAD STOPPED BREATHING FIFTEEN MINUTES BEFORE THE PARAMEDICS ARRIVED TO HER HOME. THE CUSTOMER WAS RESUSCITATED IN THE HOSPITAL, THEN THE HEART STOPPED AND WAS UNABLE TO RESUSCITATED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342485 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death