BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3092928 · Received May 3, 2013

    Report

    Report Number
    2032227-2013-01620
    Event Type
    Death
    Date Received
    May 3, 2013
    Date of Event
    February 22, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 FROM A CARDIAC ARRHYTHMIA. THE CALLER STATED THAT THE CUSTOMER HAD BEEN HOSPITALIZED FOUR TIMES FROM (B)(6) OF LAST YEAR DUE TO FREQUENT WEIGHT LOSS, FLUID IN HIS LUNGS AND A BLEEDING ULCER. THE CALLER STATED THAT THE CUSTOMER WAS ALSO IN A CONVALESENT HOME, AND THE NURSES NEGLECTED TO GIVE THE CUSTOMER INSULIN WHEN HIS BLOOD GLUCOSE WAS 900 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195190 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death