BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 4151381 · Received October 8, 2014

    Report

    Report Number
    2032227-2014-35140
    Event Type
    Death
    Date Received
    October 8, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 6, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS 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

    CUSTOMER'S FAMILY FRIEND REPORTED THAT CUSTOMER PASSED AWAY YESTERDAY ON (B)(6) 2014. CUSTOMER DROWNED AFTER FALLING IN A POND. HE WAS WEARING THE DEVICE WHEN HE PASSED AWAY. THE FAMILY CURRENTLY DOES NOT HAVE THE INSULIN PUMP BECAUSE IT IS AT THE MEDICAL EXAMINER'S OFFICE. CUSTOMER'S LAST BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER'S FAMILY WOULD LIKE TO SEND THE DEVICE BACK FOR ANALYSIS. IN SPEAKING TO THE MEDICAL EXAMINER, THE MEDICAL EXAMINER STATED THE DEVICE APPEARS TO BE WORKING EVEN THOUGH IT WAS IN THE WATER. THERE IS HALF BATTERY POWER LEFT. THE DEVICE INFORMATION COULD NOT BE DOWNLOADED. THE DEVICE WILL BE SENT BACK FOR ANALYSIS AND RETURNED TO THE FAMILY. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632688 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death