BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3901759 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-86180
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 25, 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    CUSTOMER'S FRIEND REPORTED A HOSPITALIZATION DUE TO DIABETES KETOACIDOSIS. CUSTOMER WAS VOMITING AND UNABLE TO FUNCTION. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS HIGH. HOSPITAL TREATED WITH IV AND INSULIN DRIP. THE CURRENT BLOOD GLUCOSE READING IS 371 MG/DL. TREATED WITH MANUAL INJECTION AND IV. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379504 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization