BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOF SET ULTIMATE

    MDR report key: 2072447 · Received April 22, 2011

    Report

    Report Number
    2032227-2011-01042
    Event Type
    Death
    Date Received
    April 22, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    PMA / PMN Number
    K001832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. MEDWATCH 1 OF 3 (INSULIN PUMP): 2032227-2011-00998. MEDWATCH 3 OF 3 (RESERVOIR): 3004209178-2011-81218.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED THE DEATH OF HER DAUGHTER. CAUSE OF DEATH WAS REPORTED AS UNKNOWN. CUSTOMER'S MOTHER STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF HER DEATH. CUSTOMER'S MOTHER ALSO REPORTED THAT THE RESERVOIR WAS HALF FULL AND THAT THE CUSTOMER HAD AN MRI PROCEDURE THE DAY BEFORE SHE PASSED AWAY AND CUSTOMER WAS WEARING THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOF SET ULTIMATE INFUSION SET FPA MEDTRONIC MINIMED MMT-317

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death