BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1780KPK 670G PATHWAY BLACK MG

    MDR report key: 13566071 · Received February 20, 2022

    Report

    Report Number
    2032227-2022-115798
    Event Type
    Death
    Date Received
    February 20, 2022
    Date of Event
    October 20, 2020
    Report Date
    February 20, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000643169939219
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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 · 0

    IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY AT HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2020 DUE TO SUICIDE. THE CALLER STATED THAT THE CUSTOMER HAD ATTEMPTED SUICIDE THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. IT WAS UNKNOWN IF THE CALLER WILL RETURN THE INSULIN PUMP FOR ANALYSIS. FRN-MMT-332-RSVR, UNOMED INF SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2401222 PUMP MMT-1780KPK 670G PATHWAY BLACK MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KPK HG29UDW 000000643169939219

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male Death