BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3812917 · Received May 15, 2014

    Report

    Report Number
    2032227-2014-02373
    Event Type
    Death
    Date Received
    May 15, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND A STROKE. CUSTOMER WAS RELEASED TO A NURSING HOME AND READMITTED TO THE HOSPITAL WITH ELEVATED BLOOD GLUCOSE AND PASSED AWAY. CALLER STATED THAT THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF PASSING BECAUSE IT WAS REMOVED AT THE TIME OF HOSPITALIZATION. CALLER STATED THAT THE CAUSED OF DEATH MAY BE DIABETES COMPLICATION, BUT THE DEATH CERTIFICATE HAS NOT ARRIVED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291155 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death