BEUDAMED
    FDA Adverse Event Death Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 13105245 · Received December 29, 2021

    Report

    Report Number
    2032227-2021-236456
    Event Type
    Death
    Date Received
    December 29, 2021
    Date of Event
    December 19, 2021
    Report Date
    December 29, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    CUSTOMER'S SISTER IN LAW WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY IN HIS SLEEP. BECAUSE OF INSULIN PUMP DIED CUSTOMER PASSED AWAY. CALLER MENTIONED DIABETES WHICH MAY CONTRIBUTE TO DEATH. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE DATE OF DEATH WAS (B)(6), 2021. THE CUSTOMER WAS USING INSULIN PUMP AND SENSOR AT THE TIME OF DEATH. CALLER AGREED TO RETURN INSULIN PUMP. FRN-MMT-332A-RSVR, UNOMED SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2003518 670G INSULIN PUMP MMT-1780KL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4AFYF 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Death