BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 12412585 · Received September 2, 2021

    Report

    Report Number
    2032227-2021-187743
    Event Type
    Injury
    Date Received
    September 2, 2021
    Date of Event
    August 22, 2021
    Report Date
    September 2, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. BLOOD GLUCOSE READING WAS 40MG/DL. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR THE LOW BLOOD GLUCOSE INCIDENT. IT WAS UNKNOWN THAT AUTO MODE FEATURE WAS ACTIVE OR NOT AT THE TIME OF LOW BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. FRN-UNK-RSVR, UNOMED INF FRN-SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314966 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 HG5AV8YZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR