BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS

    MDR report key: 7968453 · Received October 16, 2018

    Report

    Report Number
    2032227-2018-43454
    Event Type
    Death
    Date Received
    October 16, 2018
    Date of Event
    December 3, 2014
    Report Date
    October 16, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    UDI-DI
    00643169478602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 AT HOME. THE CAUSE OF DEATH WAS DIABETES AND DEMENTIA. THE CALLER STATED THAT THE CUSTOMER HAD NO OTHER ILLNESSES 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 AS IT'S WHEREABOUTS WERE UNKNOWN. FRN-UNK-RSVR . UNOMED SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812698 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS A4723LNASJ 00643169478602

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death