BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 9360082 · Received November 21, 2019

    Report

    Report Number
    2032227-2019-121102
    Event Type
    Death
    Date Received
    November 21, 2019
    Date of Event
    November 9, 2019
    Report Date
    November 21, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    00763000190460
    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 ON (B)(6) 2019 DUE TO A HEART ATTACK AND LOW BLOOD GLUCOSE. CUSTOMER¿S BLOOD GLUCOSE WAS BELOW 15 MG/DL. IT WAS REPORTED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. CONTINUOUS GLUCOSE MONITORING WAS NOT USED. INSULIN PUMP IS NOT EXPECTED TO RETURN FOR FAILURE ANALYSIS. UNOMED INF SET, FRN-MMT-332-RSVR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153292 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG3F5E7 00763000190460

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death