BEUDAMED
    FDA Adverse Event Death Summary report: N

    630G INSULIN PUMP MMT-1715KL 630G

    MDR report key: 12523546 · Received September 23, 2021

    Report

    Report Number
    2032227-2021-197456
    Event Type
    Death
    Date Received
    September 23, 2021
    Date of Event
    August 22, 2021
    Report Date
    September 23, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000763000166519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD PASSED AWAY ON (B)(6) 2021 AT HOME. THE CAUSE OF DEATH WAS NATURAL CAUSES. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. IT WAS UNKNOWN WHETHER THE CUSTOMER WAS NOT USING SENSOR. IT WAS UNKNOWN WHETHER THE CALLER WILL RETURNED THE INSULIN PUMP FOR ANALYSIS. FRN-MMT-332-RSVR, UNOMED SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419938 630G INSULIN PUMP MMT-1715KL 630G ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KL HG3QSP2 000000763000166519

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death FRN-MMT-332-RSVR, UNOMED SET