BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-1715KM 630G 3ML BLACK MEDI  

    MDR report key: 9844866 · Received March 17, 2020

    Report

    Report Number
    3004209178-2020-86778
    Event Type
    Death
    Date Received
    March 17, 2020
    Date of Event
    May 1, 2018
    Report Date
    March 17, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169873834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN (B)(6) OF 2018. THE CALLER STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CALLER ALSO STATED THE DEATH WAS UNEXPECTED. NO FURTHER DETAILS WERE PROVIDED AS ATTEMPTS TO REACH THE NEXT OF KIN HAVE BEEN UNSUCCESSFUL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS. FRN-UNK-RSVR, UNOMED SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305336 PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1715KM HG1QFX1 00643169873834

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death