BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 11882956 · Received May 26, 2021

    Report

    Report Number
    2032227-2021-149109
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    May 21, 2021
    Report Date
    May 25, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A HIGH BLOOD GLUCOSE VALUE OF 450 MG/DL. CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE DUE TO STEROIDS. MODE OF TREATMENT FOR HIGH BLOOD GLUCOSE EVENT IS UNKNOWN. CUSTOMER ALSO REPORTED AUTOMODE FEATURE WAS IN USE AT THE TIME OF THE EVENT. INSULIN PUP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779613 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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other