BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUMP MMT-715LNAS PRDGM INS V2.1 SK EN

    MDR report key: 1802744 · Received August 10, 2010

    Report

    Report Number
    2032227-2010-82246
    Event Type
    Death
    Date Received
    August 10, 2010
    Date of Event
    October 16, 2007
    Report Date
    July 18, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    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. THE CAUSE OF DEATH WAS DIABETIC KETOACIDOSIS. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER'S MOTHER DID NOT KNOW HOW LONG THE CUSTOMER HAD BEEN DISCONNECTED FROM THE INSULIN PUMP AT THE TIME OF DEATH. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715LNAS PRDGM INS V2.1 SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Death