BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4581079 · Received March 9, 2015

    Report

    Report Number
    3004209178-2015-99857
    Event Type
    Injury
    Date Received
    March 9, 2015
    Date of Event
    February 7, 2015
    Report Date
    February 24, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN MG/DL. THE CUSTOMER SAID THAT HE HAD BEEN HOSPITALIZED FOR A HIGH BLOOD GLUCOSE . THE CUSTOMER WAS ADVISED TO CALL BACK CAUSED OF UNABLE TO RECORD MOST OF THE INFORMATION. THE CUSTOMER SAID THAT HEW WENT TO EMERGENCY ROOM AND WAS KEPT FOR OBSERVATION OF HIS HIGH BLOOD GLUCOSE ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162335 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization