BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1714K 630G BLACK MMOL CANADA

    MDR report key: 14317155 · Received May 7, 2022

    Report

    Report Number
    2032227-2022-175037
    Event Type
    Death
    Date Received
    May 7, 2022
    Date of Event
    December 13, 2019
    Report Date
    April 3, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    000000643169782396
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    INFORMATION RECEIVED BY MEDTRONIC ON OCTOBER 25, 2021, INDICATED DECEASED REPORTING. THE CALLER REPORTED THAT THE CUSTOMER PASSED AWAY ON (B)(6) 2019. THE CUSTOMER WAS ADMITTED TO THE HOSPITAL DUE TO A LOT OF HEALTH COMPLICATIONS AND HEART ISSUES. THE PUMP WAS WORN AT THE TIME OF THE EVENT. THE PUMP WAS NOT AVAILABLE FOR TROUBLESHOOTING. IT IS UNKNOWN IF THE INSULIN PUMP WILL BE RETURNED TO MEDTRONIC FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242899 PUMP MMT-1714K 630G BLACK MMOL CANADA ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1714K HG2M452 000000643169782396

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death