BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3133989 · Received May 29, 2013

    Report

    Report Number
    2032227-2013-02060
    Event Type
    Death
    Date Received
    May 29, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 PASSED AWAY. CALLER STATED THAT THE CUSTOMER'S LAST BLOOD GLUCOSE READING WAS 20 MG/DL. CALLER STATED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO PANIC ATTACK AND LOW BLOOD GLUCOSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235511 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death