BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 4922950 · Received July 17, 2015

    Report

    Report Number
    3004209178-2015-74824
    Event Type
    Death
    Date Received
    July 17, 2015
    Date of Event
    April 14, 2015
    Report Date
    July 13, 2015
    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 CUSTOMER PASSED AWAY. THE SPOUSE OF THE DECEDENT WAS CONTACT, HOWEVER, SHE REQUESTED A CALL BACK IN A FEW DAYS; SHE WAS BUSY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN A HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2015. THE CUSTOMER PASSED AWAY ON (B)(6) 2015. THE OFFICIAL CAUSE OF DEATH, ACCORDING TO THE DEATH CERTIFICATE, WAS ACUTE LIVER FAILURE. THE CUSTOMER'S BLOOD GLUCOSE, AT THE TIME OF DEATH, WAS 130 MG/DL. THE CALLER ALSO NOTED THAT THE DECEDENT'S BLOOD GLUCOSE WAS 230 MG/DL BEFORE GOING TO THE HOSPITAL ON (B)(6) 2015. THE CALLER WAS UNSURE WHETHER THE INSULIN PUMP WAS DISCONNECTED WHILE THE CUSTOMER WAS IN THE HOSPITAL. THE CALLER WAS UNSURE WHETHER THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CALLER DID NOT KNOW WHETHER THE CUSTOMER USED SENSORS OR NOT. THE CALLER STATED THAT THEY DID NOT KNOW WHERE THE INSULIN PUMP WAS BUT AGREED TO RETURN IF FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466172 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death