BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 3903539 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-86333
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 11, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN HIS SLEEP. THE WIFE STATED THAT THE CUSTOMER HAD BEEN SICK AND WAS NOT ON THE INSULIN PUMP AT TIME OF DEATH. HIS LAST BLOOD GLUCOSE READING RECORDED IN THE GLUCOSE METER WAS 31MG/DL. IT WAS STATED THAT THE CAUSE OF DEATH WAS A HEART ATTACK. THE SPOUSE MENTIONED THAT THE CUSTOMER NEVER HAD THE CHANCE TO WEAR IT NOR TRAINING. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379454 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death