BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS

    MDR report key: 7942092 · Received October 8, 2018

    Report

    Report Number
    2032227-2018-38701
    Event Type
    Death
    Date Received
    October 8, 2018
    Date of Event
    October 12, 2017
    Report Date
    October 8, 2018
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    UDI-DI
    00613994918611
    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. 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 IN HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2017. THE CAUSE OF DEATH WAS UNKNOWN AS NO AUTOPSY WAS PERFORMED. THE CALLER STATED THAT THE CUSTOMER HAD HEART ISSUES, DIABETES, AND KIDNEY ISSUES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS. FRN-UNK-RSVR. UNOMED SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785750 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-523RNAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC MINIMED MMT-523RNAS A000204721 00613994918611

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death