BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 12682509 · Received October 22, 2021

    Report

    Report Number
    2032227-2021-208957
    Event Type
    Death
    Date Received
    October 22, 2021
    Date of Event
    October 2, 2021
    Report Date
    October 22, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000643169939219
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY IN HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2021 DUE TO MOTORCYCLE ACCIDENT. THE CAUSE OF DEATH WAS MOTOR CYCLE DEATH. THE CALLER STATED THAT THE CAUSE OF DEATH WAS BRAIN DEAD. THE CUSTOMERS BLOOD GLUCOSE WAS UNKNOWN MG/DL AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS USING SENSORS. THE AUTO MODE ON THE INSULIN PUMP WAS ACTIVE. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS. UNOMED INF SET, FRN-UNK-RSVR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1582976 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG2AP38 000000643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death UNOMED INF SET, FRN-UNK-RSVR