BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 12998891 · Received December 14, 2021

    Report

    Report Number
    2032227-2021-229942
    Event Type
    Death
    Date Received
    December 14, 2021
    Date of Event
    December 1, 2021
    Report Date
    December 14, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 IN HOSPITAL ON (B)(6) 2021. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2021 DUE TO MASSIVE INFECTION, THAT ATTACKED THE PATIENTS ORGANS . THE CAUSE OF DEATH WAS MASSIVE INFECTION, THAT ATTACKED THE PATIENTS ORGANS. THE CUSTOMER¿S BLOOD GLUCOSE WAS 850 MG/DL AT THE TIME OF HOSPITALIZATION. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS NOT USING SENSORS. IT WAS UNKNOWN IF THE AUTO MODE WAS ON. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS. FRN-MMT-332A-RSVR, INF-UNOMED SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900713 MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880 HG4TQBPZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Other