BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 6034783 · Received October 17, 2016

    Report

    Report Number
    2032227-2016-29586
    Event Type
    Death
    Date Received
    October 17, 2016
    Date of Event
    October 4, 2016
    Report Date
    October 10, 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN A HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2016. THE CALLER STATED THAT THE CUSTOMER WAS FINE ON SATURDAY BUT WOKE UP SICK AND VOMITING ON SUNDAY. TWO HOURS LATER THE CUSTOMER WAS UNRESPONSIVE, THE PARAMEDICS WERE CALLER AND TRANSPORTED THE CUSTOMER TO A HOSPITAL BY AIR. DURING TRANSPORT THE CUSTOMER WAS PLACED ON LIFE SUPPORT AND THE INSULIN PUMP WAS DISCONNECTED. THE CALLER DOES NOT HAVE THE DEATH CERTIFICATE YET. HOWEVER, THEY STATED THAT THE CUSTOMER HAD BRAIN BLEED DUE TO AN UNKNOWN CAUSE. THE CALLER DID NOT KNOW THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF DEATH. THE LAST RECORDED VALUE WAS 51 MG/DL ON (B)(6) 2016 AT 12PM. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER DECLINED RETURNING THE INSULIN PUMP. THE CALLER AGREED TO PERFORM CARELINK UPLOAD. LAST ALARM IN THE ALARM HISTORY WAS A21 ALARM. THE INSULIN PUMP WAS IN REWIND MODE. ASSISTANCE WAS PROVIDED TO CLEAR THE ALARM, REWIND THE DEVICE, AND UPLOAD TO CARELINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684831 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death