BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 3903552 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-86342
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    November 27, 2013
    Report Date
    January 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 PATIENT PASSED AWAY. THE CALLER HAD NO INFORMATION REGARDING THE PATIENT'S DEATH. HE ONLY STATED THAT THE PATIENT WAS WEARING THE PUMP, BUT THE HCP WAS UNCERTAIN ABOUT THE CAUSE OF DEATH. THE CALLER STATED THAT HE RECEIVED A BILL, AND HE WANTED TO TAKE CARE OF IT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379176 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death