BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 6166870 · Received December 12, 2016

    Report

    Report Number
    2032227-2016-49216
    Event Type
    Death
    Date Received
    December 12, 2016
    Date of Event
    August 18, 2016
    Report Date
    December 6, 2016
    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. A REQUEST TO RETURN THE DEVICE HAS BEEN MADE AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN A MOTEL ROOM. THE CAUSE OF DEATH WAS DIABETIC KETOACIDOSIS AND HEART FAILURE. THE CALLER STATED THAT THE CUSTOMER WAS SICK AND WAS SEEING LIVER AND LUNG SPECIALIST. THE CUSTOMER HAD VASCULAR HEART DISEASE. THE CALLER DID NOT KNOW THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS USING SENSORS HOWEVER, THE CALLER WAS UNSURE WHETHER THE CUSTOMER WAS WEARING A SENSOR AT THE TIME OF DEATH OR NOT. THE CALLER AGREED RETURNING THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817981 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death